Ronald Gottschalk - Academia.edu (original) (raw)

Papers by Ronald Gottschalk

PubMed, Feb 1, 2012

Objective: Calcitriol 3µg/g ointment has been shown to be a safe and effective treatment for adul... more Objective: Calcitriol 3µg/g ointment has been shown to be a safe and effective treatment for adults with mild-to-moderate plaque psoriasis. This analysis evaluated the response to calcitriol 3µg/g ointment relative to baseline disease. Design: Retrospective analysis of data from a 12-month safety and tolerability trial. Setting and participants: At baseline, 40.1 percent (130/324) of patients had an affected body surface area of 11 to 20 percent, and 55.2 percent (179/324) had moderate and 25.9 percent (84/324) had severe disease according to global severity score. Patients applied calcitriol 3µg/g ointment twice daily for up to 52 weeks. Measurements: Change in investigator's global severity scores and involved body surface area at Week 26 (N=249) and Week 52 (N=130) relative to baseline. Results: Compared with baseline, most patients experienced at least a 1-grade improvement in global severity score at Weeks 26 (195/249, 78.3%) and 52 (109/130, 83.8%). Stabilization (i.e., no change in global severity score) was reported in 19.3 percent (48/249) at Week 26 and in 12.3 percent (16/130) at Week 52. Most patients also experienced at least a 1-grade improvement in body surface area involved at Weeks 26 (152/249, 61.0%) and 52 (95/130, 73.1%). Stabilization (no change in affected body surface area) was reported in 32.5 percent (81/249) at Week 26 and 24.6 percent (32/130) at Week 52. The proportion of patients experiencing improvement in global severity score and body surface area was comparable across all categories of severity and disease extent at baseline. Conclusion: This analysis suggests that calcitriol 3µg/g ointment use for 26 weeks (N=249) and 52 weeks (N=130) was associated with disease improvement or stabilization in most patients with plaque psoriasis.

PubMed, Oct 1, 2012

Rosacea is often under-recognized or misdiagnosed in patients with skin of color (Fitzpatrick Ski... more Rosacea is often under-recognized or misdiagnosed in patients with skin of color (Fitzpatrick Skin Types [FST] IV-VI). Subtle clinical features and a low index of suspicion likely contribute to less frequent diagnosis in this population. Clinical trials of therapeutic agents for rosacea generally include few patients from nonwhite racial/ethnic groups and therefore, potential differences in treatment outcomes have not been previously studied. The objective of this prospective analysis was to fill the gap in knowledge of the effectiveness and safety of treatment for rosacea in patients with skin of color. We analyzed data from 826 adults aged ≥ 18 years with papulopustular (subtype 2) rosacea (663 FST I-III; 163 FST IV-VI). All patients received doxycycline 40 mg capsules (30 mg immediate release and 10 mg delayed release beads) once daily as monotherapy for 12 weeks in this open-label, multicenter, community-based study. Investigators assessed disease severity with the Investigator's Global Assessment (IGA) and erythema with the Clinician's Erythema Assessment (CEA). Significant improvement in disease severity and erythema was obtained in patients with FST I-III and IV-VI at week 12 (P<.001). Treatment success, defined as an IGA score of 0 or 1 was achieved in 74.6% and 74.3% of patients with FST I-III and IV-VI, respectively. Approximately 12% of patients experienced adverse events with no difference between the two skin type groups. The results of this prospective subgroup analysis of data from a large community-based trial suggest that doxycycline produced similar effectiveness and safety profiles in patients with FST I-III and IV-VI.

Journal of Dermatological Treatment, Sep 1, 2003

Measurement of psoriasis disease severity and effectiveness of treatment involves both objective ... more Measurement of psoriasis disease severity and effectiveness of treatment involves both objective and subjective assessments.1 Comparing the efficacy of different treatments is complicated by the use of different metrics for measuring outcomes.2 Because these measures are not used routinely in clinical practice, interpreting these data, in particular assessing the degree of clinically meaningful improvement, is difficult. The drug approval process and product labeling reflect historical changes in standards of efficacy measurement.3 This paper reviews the metrics used to evaluate psoriasis treatment and compares available information on approved treatments for severe psoriasis. It further attempts to elucidate the value of these metrics and provide some guidance in properly evaluating the relative efficacy of current proven therapy with new treatments. While clinical trials are somewhat artificial, they provide proof that a drug is more effective than placebo. Efficacy in clinical practice, however, may be very different from the clinical trial setting. Comparison of efficacy under the current circumstances of varying evaluative metrics scales is possible with proper knowledge of the functionality of these methods.

Journal of Managed Care Pharmacy, 2003

are the claims of the authors that up to 70% of patients had not received a trial of a topical re... more are the claims of the authors that up to 70% of patients had not received a trial of a topical retinoid before oral isotretinoin therapy, even though the product labeling advises that oral isotretinoin (Accutane) should be used only in patients unresponsive to "conventional therapy." The authors failed to note that "conventional therapy" as defined in the Accutane U.S. package insert includes systemic antibiotics. Therefore, the failure to note the percentage of patients who had received oral antibiotics (i.e., tetracycline, minocycline, doxycycline, and erythromycin) as a precursor therapy to Accutane is misleading. In fact, data from the Accutane Survey, which was previously conducted by the Slone Epidemiology Center, Boston University School of Public Health, a long-term epidemiologic study, revealed that 93% of all female respondents indicated that they had been on an oral antibiotic previously for their acne (N=36,481), 74% on a topical tretinoin (N=29,078), and 73% on a benzoyl peroxide (N=28,913) (Data on file, covering the time period of January 1, 1995, to June 30, 2002). Further, the authors stated that more than one quarter of patients continued a course of treatment for longer than the 15 to 20 weeks advised in the product labeling. A recent study conducted using national drug c ode health data indicated that the average length of therapy for an Accutane patient is approximately 98.7 days or 14.1 weeks (Roche, data on file, 2002). It should also be noted that Accutane packaging comes in blister packs containing a 10-day supply (10 mg, 20 mg, and 40 mg), so each patient would receive 3 to 6 packs per month. Depending on how the packages were counted, it could lead to a perception on the part of the authors that therapy was "prolonged" when, in fact, the prescriber may be within the recommended dosage of 0.5 mg/kg to 2.0 mg/kg body mass or 120 mg/kg total dose over a course of treatment. The authors report that only 52% of oral isotretinoin prescriptions were written by dermatologists. As the authors presented a limited description of the HMO and its policy and procedures, it is unclear if there is a policy that would limit the number of specialist referrals a nondermatologist could make for dermatologic conditions such as acne. According to the authors, this particular HMO has in place "a prior-authorization policy for topical tazarotene and adapalene, and in patients aged 25 or older (aged 35 in some cases) for topical tretinoin." This policy appears to be in place to limit prescriptions for topical retinoids used in photo-aging. Nondermatologists unfamiliar with other acne therapies thus may have prescribed isotretinoin inappropriately in the context of an HMO trying to limit use of topical retinoids for photo-aging. The extent of this type of prescribing after denial of topical retinoids could not be determined from the database, as the authors state. A study conducted by IMS indicated that in the years 1995 through 1997, more than 97% of the Accutane prescriptions written for an acne indication were done so by a dermatologist (Roche, data on file). Conclusions of the authors regarding the use of oral isotretinoin without first receiving "conventional therapy" and that oral isotretinoin is being used for a longer period of time than recommended are both inaccurate and misleading.

PubMed, Jul 12, 2012

Two separate single-center, randomized, evaluator-blinded, bilateral (split-face) comparison stud... more Two separate single-center, randomized, evaluator-blinded, bilateral (split-face) comparison studies compared the tolerability of adapalene 0.1% cream with adapalene 0.1% lotion in individuals with healthy skin treated once per day for 3 weeks. At each visit, the participants were graded on erythema, scaling, dryness, and stinging/burning (scale: 0 = none to 3 = severe). On the final study visit, the participants completed a Cosmetic Acceptability Questionnaire. Adverse events were recorded at each study visit. A total of 144 participants were enrolled and 130 completed the studies (study 1, n = 66; study 2, n = 64). The lotion formulation was non-inferior to the cream for the success rates and tolerability assessments in both studies. The frequency distributions of worst scores of either 0 (none) or 1 (mild) (study 1; study 2) for adapalene lotion were erythema (98.5%; 40.7%), scaling (100%; 73.5%), dryness (100%; 68.8%), and stinging/burning (98.5%; 100%). The most common treatment-related adverse event was dryness (study 1, cream 2.7% [2 of 75] and lotion 4.0% [3/75]); study 2, cream 2.9% [2 of 69] and lotion 4.3% [3 of 69]. Both the adapalene 0.1% cream and 0.1% lotion formulations were well tolerated and acceptable to the study participants. The adapalene 0.1% lotion provides clinicians with a retinoid for the treatment of acne in a lotion formulation.

PubMed, Feb 1, 2011

Objective: To compare the functional stability of Cetaphil UVA/UVB Defense SPF 50 as measured by ... more Objective: To compare the functional stability of Cetaphil UVA/UVB Defense SPF 50 as measured by its ultraviolet B sun protection factor (UVB-SPF) and ultraviolet A protection factor (UVA-PF) values following exposure to natural sunlight versus the UVB-SPF and UVA-PF values of unexposed product. Methods: These two randomized, controlled, evaluator-blinded, single-center trials were conducted according to the methods outlined in the 2007 Proposed Amendment to the Final Monograph, “Sunscreen Drug Products for Over-the-Counter Human Use.” Sunscreen samples were applied to glass plates and exposed to ultraviolet radiation in the form of natural sunlight in four minimal erythemal doses (MED) ranging from 2–6 MED (42–36 mJ/cm2). Three test sites were identified on the back of each study subject. Exposed sunscreen (one of four doses), unexposed sunscreen, and a UVB-SPF 15 control sunscreen were applied to the three test sites in a randomized fashion, followed by UV irradiation of incremental doses. Erythema and pigment darkening responses were assessed immediately following UV exposure and again 16–24 hours (erythema) or three to 24 hours (pigment darkening) after exposure. UVB-SPF and UVA-PF values were calculated for the exposed and unexposed samples. Results: The calculated UVB-SPF and UVA-PF values for all test samples (exposed and unexposed) were >50 and >9, respectively, which were greater than the stated UVB-SPF and UVA-PF values on the product label. No differences were observed between the exposed and unexposed samples in UVB-SPF or UVA-PF. Conclusion: The UVA and UVB protection using standard evaluation techniques of Cetaphil UVA/UVB Defense SPF 50 remains stable despite exposure of the sunscreen to natural sunlight containing UVB ranging from 2–16 MED (41–336 mJ/cm2) and coexistent UVA.

PubMed, 2009

Topical corticosteroids are widely used in the treatment of psoriasis. This study was conducted t... more Topical corticosteroids are widely used in the treatment of psoriasis. This study was conducted to compare the efficacy and safety of clobetasol propionate (CP) 0.005% spray to calcipotriene 0.005%-betamethasome diproprionate 0.064% (C-BD) ointment in patients with moderate to severe plaque psoriasis. Assessments were made at baseline, week 2, week 4 (end of treatment) and week 8 (4 weeks posttreatment). An assessment for Overall Disease Severity (ODS) found that 75% of CP spray-treated patients achieved a rating of clear or almost clear after 4 weeks of treatment compared to 45% of C-BD ointment-treated patients (P=.003). Adverse events were reported by less than one-third of patients from each treatment group (31% for CP spray and 33% for C-BD ointment).

PubMed, May 1, 2011

Background: A gel combination treatment containing a retinoid (adapalene 0.1%) and an antimicrobi... more Background: A gel combination treatment containing a retinoid (adapalene 0.1%) and an antimicrobial (benzoyl peroxide 2.5%) has been shown to be an effective treatment for acne vulgaris, addressing three of the four pathogenic factors (hyperkeratinization, Propionibacterium acnes proliferation, inflammation) without contributing to the incidence of Propionibacterium acnes antibiotic resistance as neither the retinoid nor benzoyl peroxide creates selective pressure for resistance. Objective: To evaluate the effectiveness of an adapalene-benzoyl peroxide gel combination in reducing antibiotic-sensitive and resistant strains of Propionibacterium acnes on the facial skin of volunteers. Methods: This four-week, open-label, single-center study included 30 healthy adults with high facial Propionibacterium acnes populations [>10(4) colony-forming units per square centimeter of skin (CFU/cm(2))] and presence of subpopulations resistant to erythromycin, tetracycline, and clindamycin. The gel was applied once daily to the forehead. Cultures for total and antibiotic-resistant Propionibacterium acnes were obtained from the forehead area at screening, Baseline, Week 2, and Week 4. Results: Total Propionibacterium acnes counts decreased by 1.1 log(10) CFU/cm(2) after two weeks of treatment, and by 1.6 log10 CFU/cm(2) after four weeks. All subjects had strains resistant to each of the five antibiotics at baseline. Mean counts of erythromycin and clindamycin resistant Propionibacterium acnes were high at baseline (5.37 and 5.28 log(10) CFU/cm(2), respectively) and decreased by ≥2.1 log(10) by Week 4 (P<0.001). Mean counts of strains resistant to tetracyclines were lower at baseline (3.8 to 4.2 CFU/cm(2)) and decreased by 1.9 (tetracycline), 2.4 (minocycline), and 1.3 (doxycycline) log(10) CFU/cm(2) by Week 4 (P<0.001). Limitations: Although limited in scope, the results of the present study demonstrate that the fixed-dose combination gel containing adapalene 0.1% and benzoyl peroxide 2.5% effectively inhibited both antibiotic-susceptible and antibiotic-resistant Propionibacterium acnes. In addition to reducing population densities, therapy with adapalene-benzoyl peroxide eradicated some resistant strains entirely in some individual subjects. Conclusion: Topical adapalene-benzoyl peroxide gel effectively reduced skin colonization by antibiotic-sensitive and antibiotic-resistant Propionibacterium acnes after four weeks. This trial was registered with ClinicalTrials.gov (http://clinicaltrials.gov/), registry number NCT00907101.

Journal of The American Academy of Dermatology, Jun 1, 2010

Background: Melasma is often recalcitrant to treatment. Triple combination (TC) cream is an effec... more Background: Melasma is often recalcitrant to treatment. Triple combination (TC) cream is an effective and approved treatment for melasma. Objective: We sought to determine the efficacy and safety of continuous therapy followed by a maintenance treatment regimen during a period of 24 weeks with a TC cream containing hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%. Methods: Seventy patients with melasma were treated with a TC cream daily for 12 weeks, after which, if clear or almost clear, they applied the cream twice per week for 12 more weeks. For patients who were not clear or almost clear after 12 weeks, daily treatment was continued. Results: In all, 25 patients completing the study per protocol were treated daily for 24 weeks (cohort A); 6 patients were treated daily for 12 weeks followed by 12 weeks of maintenance therapy (cohort B); and 21 patients were treated daily for 12 weeks, relapsed during the maintenance phase, and returned to daily dosing (cohort C). Pigmentation was significantly reduced at weeks 12 and 24 and global melasma severity improved at week 24 in cohorts A and C compared with baseline. Adverse events occurred in 53% of patients and were primarily mild in severity. Limitations: This was an open-label trial. Conclusion: About half of patients treated with a TC cream for melasma were able to begin maintenance therapy twice per week after 12 weeks; however, relapses occurred in most of these patients, requiring resumption of daily therapy. The cream is safe in the treatment of moderate to severe melasma for up to 24 weeks when used intermittently or continuously. Significant reductions in melasma severity scores were seen at weeks 12 and 24 when compared with baseline scores in all evaluable study groups (

Dermatologic Surgery, Feb 1, 2011

BACKGROUND Triple combination (TC) cream is a stable combination of fluocinolone acetonide 0.01%,... more BACKGROUND Triple combination (TC) cream is a stable combination of fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05% and is currently the only hydroquinone-containing drug approved by the Food and Drug Administration for the treatment of melasma. OBJECTIVE To evaluate the safety and efficacy of TC cream when used sequentially with intense pulsed light (IPL) treatments in patients with moderate to severe melasma. MATERIALS & METHODS This was a 10-week, split-face study in which 56 patients with symmetrical melasma lesions were treated with TC cream on one side of the face and an inactive control cream on the other side of the face. Patients also had two IPL treatments at weeks 2 and 6. (Topical treatment was suspended during IPL treatments 7 1 day.) RESULTS Melasma severity was significantly less with TC cream and IPL than with inactive cream and IPL at weeks 6 (p = .007) and 10 (p = .002). Improvement in melasma was greater with TC cream and IPL than with inactive cream and IPL according to investigator and patient evaluations at weeks 6 and 10 (po.001 for both time points). Treatment with TC cream and IPL was well tolerated. CONCLUSION The results of this study suggest that TC cream and IPL treatment is an effective and safe treatment option for patients with melasma.

PubMed, Oct 1, 2011

High-potency topical corticosteroids are the cornerstone of psoriasis therapy. Although highly ef... more High-potency topical corticosteroids are the cornerstone of psoriasis therapy. Although highly effective, long-term use of topical steroids can cause adverse side effects. Additionally, steroids alone do not address the multiple pathophysiologic factors that cause the disease. Psoriasis regimens that utilize high-potency steroids combined with nonsteroid-containing products such as vitamin D analogs have been used for many years to manage the disease, not only for the short-term treatment of the disease but also for long-term treatment to minimize the recurrence of symptoms. We report an open-label, multicenter study designed to evaluate a weekday/ weekend treatment regimen involving calcitriol ointment 3 microg/g and clobetasol propionate spray 0.05% for moderate plaque psoriasis. Participants applied calcitriol ointment 3 microg/g twice daily on the weekdays and clobetasol propionate spray 0.05% twice daily on the weekends for up to 4 weeks. Participants were evaluated at baseline, week 2, and week 4. The results of this study demonstrate that a 4-week regimen of calcitriol ointment 3 microg/g treatment on weekdays and clobetasol propionate spray 0.05% on weekends is effective and well-tolerated for the treatment of moderate plaque psoriasis.

PubMed, Jul 1, 2011

Psoriasis is a chronic condition with serious quality-of-life ramifications. Dermatologists seek ... more Psoriasis is a chronic condition with serious quality-of-life ramifications. Dermatologists seek alternative treatments of patients with plaque psoriasis that provide both efficacy and safety while minimizing exposure to high-potency steroids that can have adverse effects following long-term use. We report an open-label, multicenter study designed to evaluate a morning/evening (AM/PM) treatment regimen involving clobetasol propionate spray 0.05% and calcitriol ointment 3 microg/g for moderate plaque psoriasis. Participants applied clobetasol propionate spray 0.05% in the morning and calcitriol ointment 3 microg/g in the evening for up to 4 weeks. Participants were evaluated at baseline, week 2, and week 4. The results of this study indicate that a 4-week regimen of clobetasol propionate spray 0.05% treatment in the morning and calcitriol ointment 3 microg/g in the evening is efficacious and without unexpected safety issues for the management of moderate plaque psoriasis.

Melanoma Research, Jun 1, 2010

Journal of Drugs in Dermatology, Jun 1, 2008

A variety of topical retinoids is available for the treatment of acne vulgaris. Selection of the ... more A variety of topical retinoids is available for the treatment of acne vulgaris. Selection of the appropriate treatment depends not only on efficacy but also on how well the patient can tolerate different formulations. The goal of this study was to evaluate the efficacy and tolerability of daily adapalene 0.1% gel compared to daily tazarotene 0.1% cream and to demonstrate the noninferiority of adapalene 0.1% gel when compared to tazarotene 0.1% cream in treating acne. This represents 2 arms of a 3-arm study. Subjects 12 to 35 years of age with acne vulgaris (N=202) participated in a 12-week, randomized, evaluator-blinded study of once-daily therapy with adapalene 0.1% gel versus tazarotene 0.1% cream. The primary measure of efficacy was the reduction in total lesion counts posttreatment. Subjects treated with adapalene 0.1% gel achieved similar reductions in total lesion counts at week 12 compared to the subjects treated with the tazarotene cream, which demonstrates the noninferiority of adapalene treatment compared to tazarotene (median difference: -1.18%; lower confidence limit [LCL]: -9.26). At week 2, the number of patients that experienced erythema and scaling with tazarotene 0.1% cream was greater when compared to adapalene 0.1% gel and statistically significant. By week 12, the percentage of subjects reporting cutaneous irritation had returned to or near baseline levels and was similar between treatment arms for all parameters assessed. Adapalene gel was associated with fewer treatment-related adverse events than tazarotene cream (36% versus 58%, respectively), and less than half as many adverse events that were &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;definitely&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; related to study treatment than tazarotene cream (20% versus 45%, respectively). Daily therapy with adapalene 0.1% gel was shown to be noninferior to tazarotene 0.1% cream in total acne lesion reductions, and during initial stages of treatment, demonstrated better tolerability with respect to erythema and scaling.

PubMed, Feb 1, 2011

Background: Psoriasis is a hyperproliferative and inflammatory skin disorder that affects roughly... more Background: Psoriasis is a hyperproliferative and inflammatory skin disorder that affects roughly 2 percent of the worldwide population. Clobetasol propionate is the most common corticosteroid used to treat moderate-to-severe psoriasis but the potential for side effects limits its long-term use. Topical vitamin D, which is used to treat mild-to-moderate psoriasis, has been shown to be safe when used daily for up to 52 weeks. To date, very few studies exist evaluating the use of clobetasol propionate in a regimen with calcitriol to manage moderate-to-severe disease over time. Objectives: To evaluate the efficacy and assess safety of a regimen of sequential topical treatments with clobetasol propionate 0.05% spray for up to four weeks followed by calcitriol 3 μg/g ointment for eight weeks in the management of moderate-to-severe plaque psoriasis. Methods: This was a multi-center, open-label study in subjects aged 18-80 years with moderate-to-severe plaque psoriasis at baseline. Subjects applied clobetasol propionate 0.05% spray twice daily for up to four weeks. At the end of four weeks, if the subject's overall disease severity (ODS) was assessed as clear, almost clear, mild or moderate, subjects started treatment with calcitriol 3 μg/g ointment twice daily. Twice-daily treatment with calcitriol 3 μg/g ointment continued for eight weeks (until week 12) or unless the subject's ODS was assessed as severe or returned to the baseline score, at which time it was discontinued. Subjects were evaluated at baseline and at weeks 2, 4, 8 and 12. Results: Of the 305 subjects enrolled, 170 subjects completed the full 12-week study with no major protocol deviations and comprised the per-protocol (PP) study population. Treatment success, defined as at least one grade improvement in ODS at week 12 compared to baseline, was achieved in 84.1 percent of subjects. The percent body surface area affected (% BSA) decreased from 7.1 percent at baseline to 3.9 percent at week 12 (P<0.001). The sequential treatment regimen was well tolerated with no unexpected adverse events. Most reported adverse events and cutaneous irritations were mild in severity. Conclusions: The results of this study indicate that the 12-week regimen of clobetasol propionate 0.05% spray treatment for four weeks immediately followed by an eight-week treatment phase with calcitriol 3 μg/g ointment is efficacious and safe for the management of moderate-to-severe plaque psoriasis.

Journal of Cosmetic and Laser Therapy, Mar 14, 2011

This report documents the optical characteristics of a number of photodynamic therapy (PDT) light... more This report documents the optical characteristics of a number of photodynamic therapy (PDT) light sources of varied types, measured and indexed relative to estimated effectiveness for activation of the PDT chromaphore protoporphyrin IX (PpIX). PDT sources in use at several clinics, including intense pulsed light (IPL) sources, lasers, and continuous wave (CW) light sources, were spectroradiometrically measured and indexed relative to their overlap to an absorption spectrum of PpIX. The sources were highly disparate, varying in power from irradiance in the mW/cm(2) range for the CW sources up to ∼30 J/cm(2) per flash for the IPL sources. Our PpIX Index ranged by a factor of nearly 100 (0.008-0.630) in estimated PpIX PDT effectiveness following the distinct spectral characteristics of the light sources surveyed. Application of this PpIX Index, tempered with an understanding of the biology of the lesion being treated and effective spectrum of the light source reaching the lesion requiring therapy, provides a rational algorithm to approximate equivalent light doses prior to clinical protocols to establish equivalent patient outcomes employing alternative PDT light sources.

Journal of The American Academy of Dermatology, 2011

Background: The Melasma Area and Severity Index (MASI), the most commonly used outcome measure fo... more Background: The Melasma Area and Severity Index (MASI), the most commonly used outcome measure for melasma, has not been validated. Objective: We sought to determine the reliability and validity of the MASI. Methods: After standardized training, 6 raters independently rated 21 patients with mild to severe melasma once daily over a period of 2 days to determine intrarater and interrater reliability. Validation was performed by comparing the MASI with the melasma severity scale. The darkness component of the MASI was validated by comparing it with the difference between mexameter scores for affected versus adjacent normal-appearing skin. The area component of the MASI was validated by comparing it with the area of each section of the face determined by computer-based measurement software. Results: The MASI score showed good reliability within and between raters and was found to be valid when compared with the melasma severity scale, mexameter scores, and area measurements. Homogeneity assessment by raters showed the least agreement and can be removed from the MASI score without any loss of reliability. Limitations: Patients were limited to Hispanic, African, and Asian backgrounds. Conclusion: The MASI is a reliable measure of melasma severity. Area of involvement and darkness are sufficient for accurate measurement of the severity of melasma and homogeneity can be eliminated.

Cutis, May 1, 2011

The purpose of this study was to assess the cosmetic appearance of commonly marketed facial cosme... more The purpose of this study was to assess the cosmetic appearance of commonly marketed facial cosmetics when used after the application of metronidazole gel 1%. An observational. open-label, single-site study was conducted with women (N=30) aged 20 to 75 years and diagnosed with moderate papulopustular rosacea (investigator global severity score of 3). After cleansing the face with a gentle skin cleanser, participants applied metronidazole gel 1% once daily before applying their usual facial foundation. Two surveys were conducted: (1) investigator assessment of cosmetic appearance; and (2) participant assessment of cosmetic appearance. The investigator also evaluated erythema, disease severity, and tolerability at baseline and week 2. Adverse events were collected. The 28 per-protocol (PP) participants had a mean age (standard deviation [SD]) of 54.0 (10.3) years and a mean duration (SD) of rosacea of 15.4 (13.2) years. The median response score for both the investigator and participant assessments of cosmetic appearance was 10 (best) for each survey question. Signs and symptoms of rosacea did not increase with use of metronidazole gel 1% and the participants&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; selected cosmetic regimen. At baseline all 28 participants were classified as having moderate erythema. At week 2, 18 (64%) participants were classified as having moderate erythema and 10 (36%) mild. At baseline all 28 (100%) participants were classified as having moderate rosacea according to the investigator global severity score. At week 2, 10 (36%) participants were classified as mild and 18 (64%) moderate. In addition, few participants reported cutaneous irritation during the study. At week 2, 10 participants had dryness, 2 had itching, 8 had scaling, and 2 had stinging/burning. According to surveys completed by the investigator and the participants themselves, most participants had a good cosmetic appearance with their facial foundation cosmetics that were applied after metronidazole gel 1%. The use of various cosmetic regimens after application of metronidazole gel 1% did not cause rosacea symptoms to worsen and treatment was well-tolerated.

Journal of the American Academy of Dermatology, 2011

Background: The Melasma Area and Severity Index (MASI), the most commonly used outcome measure fo... more Background: The Melasma Area and Severity Index (MASI), the most commonly used outcome measure for melasma, has not been validated. Objective: We sought to determine the reliability and validity of the MASI. Methods: After standardized training, 6 raters independently rated 21 patients with mild to severe melasma once daily over a period of 2 days to determine intrarater and interrater reliability. Validation was performed by comparing the MASI with the melasma severity scale. The darkness component of the MASI was validated by comparing it with the difference between mexameter scores for affected versus adjacent normal-appearing skin. The area component of the MASI was validated by comparing it with the area of each section of the face determined by computer-based measurement software. Results: The MASI score showed good reliability within and between raters and was found to be valid when compared with the melasma severity scale, mexameter scores, and area measurements. Homogeneity assessment by raters showed the least agreement and can be removed from the MASI score without any loss of reliability. Limitations: Patients were limited to Hispanic, African, and Asian backgrounds. Conclusion: The MASI is a reliable measure of melasma severity. Area of involvement and darkness are sufficient for accurate measurement of the severity of melasma and homogeneity can be eliminated.

PubMed, Feb 1, 2012

Objective: Calcitriol 3µg/g ointment has been shown to be a safe and effective treatment for adul... more Objective: Calcitriol 3µg/g ointment has been shown to be a safe and effective treatment for adults with mild-to-moderate plaque psoriasis. This analysis evaluated the response to calcitriol 3µg/g ointment relative to baseline disease. Design: Retrospective analysis of data from a 12-month safety and tolerability trial. Setting and participants: At baseline, 40.1 percent (130/324) of patients had an affected body surface area of 11 to 20 percent, and 55.2 percent (179/324) had moderate and 25.9 percent (84/324) had severe disease according to global severity score. Patients applied calcitriol 3µg/g ointment twice daily for up to 52 weeks. Measurements: Change in investigator's global severity scores and involved body surface area at Week 26 (N=249) and Week 52 (N=130) relative to baseline. Results: Compared with baseline, most patients experienced at least a 1-grade improvement in global severity score at Weeks 26 (195/249, 78.3%) and 52 (109/130, 83.8%). Stabilization (i.e., no change in global severity score) was reported in 19.3 percent (48/249) at Week 26 and in 12.3 percent (16/130) at Week 52. Most patients also experienced at least a 1-grade improvement in body surface area involved at Weeks 26 (152/249, 61.0%) and 52 (95/130, 73.1%). Stabilization (no change in affected body surface area) was reported in 32.5 percent (81/249) at Week 26 and 24.6 percent (32/130) at Week 52. The proportion of patients experiencing improvement in global severity score and body surface area was comparable across all categories of severity and disease extent at baseline. Conclusion: This analysis suggests that calcitriol 3µg/g ointment use for 26 weeks (N=249) and 52 weeks (N=130) was associated with disease improvement or stabilization in most patients with plaque psoriasis.

PubMed, Oct 1, 2012

Rosacea is often under-recognized or misdiagnosed in patients with skin of color (Fitzpatrick Ski... more Rosacea is often under-recognized or misdiagnosed in patients with skin of color (Fitzpatrick Skin Types [FST] IV-VI). Subtle clinical features and a low index of suspicion likely contribute to less frequent diagnosis in this population. Clinical trials of therapeutic agents for rosacea generally include few patients from nonwhite racial/ethnic groups and therefore, potential differences in treatment outcomes have not been previously studied. The objective of this prospective analysis was to fill the gap in knowledge of the effectiveness and safety of treatment for rosacea in patients with skin of color. We analyzed data from 826 adults aged ≥ 18 years with papulopustular (subtype 2) rosacea (663 FST I-III; 163 FST IV-VI). All patients received doxycycline 40 mg capsules (30 mg immediate release and 10 mg delayed release beads) once daily as monotherapy for 12 weeks in this open-label, multicenter, community-based study. Investigators assessed disease severity with the Investigator's Global Assessment (IGA) and erythema with the Clinician's Erythema Assessment (CEA). Significant improvement in disease severity and erythema was obtained in patients with FST I-III and IV-VI at week 12 (P<.001). Treatment success, defined as an IGA score of 0 or 1 was achieved in 74.6% and 74.3% of patients with FST I-III and IV-VI, respectively. Approximately 12% of patients experienced adverse events with no difference between the two skin type groups. The results of this prospective subgroup analysis of data from a large community-based trial suggest that doxycycline produced similar effectiveness and safety profiles in patients with FST I-III and IV-VI.

Journal of Dermatological Treatment, Sep 1, 2003

Measurement of psoriasis disease severity and effectiveness of treatment involves both objective ... more Measurement of psoriasis disease severity and effectiveness of treatment involves both objective and subjective assessments.1 Comparing the efficacy of different treatments is complicated by the use of different metrics for measuring outcomes.2 Because these measures are not used routinely in clinical practice, interpreting these data, in particular assessing the degree of clinically meaningful improvement, is difficult. The drug approval process and product labeling reflect historical changes in standards of efficacy measurement.3 This paper reviews the metrics used to evaluate psoriasis treatment and compares available information on approved treatments for severe psoriasis. It further attempts to elucidate the value of these metrics and provide some guidance in properly evaluating the relative efficacy of current proven therapy with new treatments. While clinical trials are somewhat artificial, they provide proof that a drug is more effective than placebo. Efficacy in clinical practice, however, may be very different from the clinical trial setting. Comparison of efficacy under the current circumstances of varying evaluative metrics scales is possible with proper knowledge of the functionality of these methods.

Journal of Managed Care Pharmacy, 2003

are the claims of the authors that up to 70% of patients had not received a trial of a topical re... more are the claims of the authors that up to 70% of patients had not received a trial of a topical retinoid before oral isotretinoin therapy, even though the product labeling advises that oral isotretinoin (Accutane) should be used only in patients unresponsive to "conventional therapy." The authors failed to note that "conventional therapy" as defined in the Accutane U.S. package insert includes systemic antibiotics. Therefore, the failure to note the percentage of patients who had received oral antibiotics (i.e., tetracycline, minocycline, doxycycline, and erythromycin) as a precursor therapy to Accutane is misleading. In fact, data from the Accutane Survey, which was previously conducted by the Slone Epidemiology Center, Boston University School of Public Health, a long-term epidemiologic study, revealed that 93% of all female respondents indicated that they had been on an oral antibiotic previously for their acne (N=36,481), 74% on a topical tretinoin (N=29,078), and 73% on a benzoyl peroxide (N=28,913) (Data on file, covering the time period of January 1, 1995, to June 30, 2002). Further, the authors stated that more than one quarter of patients continued a course of treatment for longer than the 15 to 20 weeks advised in the product labeling. A recent study conducted using national drug c ode health data indicated that the average length of therapy for an Accutane patient is approximately 98.7 days or 14.1 weeks (Roche, data on file, 2002). It should also be noted that Accutane packaging comes in blister packs containing a 10-day supply (10 mg, 20 mg, and 40 mg), so each patient would receive 3 to 6 packs per month. Depending on how the packages were counted, it could lead to a perception on the part of the authors that therapy was "prolonged" when, in fact, the prescriber may be within the recommended dosage of 0.5 mg/kg to 2.0 mg/kg body mass or 120 mg/kg total dose over a course of treatment. The authors report that only 52% of oral isotretinoin prescriptions were written by dermatologists. As the authors presented a limited description of the HMO and its policy and procedures, it is unclear if there is a policy that would limit the number of specialist referrals a nondermatologist could make for dermatologic conditions such as acne. According to the authors, this particular HMO has in place "a prior-authorization policy for topical tazarotene and adapalene, and in patients aged 25 or older (aged 35 in some cases) for topical tretinoin." This policy appears to be in place to limit prescriptions for topical retinoids used in photo-aging. Nondermatologists unfamiliar with other acne therapies thus may have prescribed isotretinoin inappropriately in the context of an HMO trying to limit use of topical retinoids for photo-aging. The extent of this type of prescribing after denial of topical retinoids could not be determined from the database, as the authors state. A study conducted by IMS indicated that in the years 1995 through 1997, more than 97% of the Accutane prescriptions written for an acne indication were done so by a dermatologist (Roche, data on file). Conclusions of the authors regarding the use of oral isotretinoin without first receiving "conventional therapy" and that oral isotretinoin is being used for a longer period of time than recommended are both inaccurate and misleading.

PubMed, Jul 12, 2012

Two separate single-center, randomized, evaluator-blinded, bilateral (split-face) comparison stud... more Two separate single-center, randomized, evaluator-blinded, bilateral (split-face) comparison studies compared the tolerability of adapalene 0.1% cream with adapalene 0.1% lotion in individuals with healthy skin treated once per day for 3 weeks. At each visit, the participants were graded on erythema, scaling, dryness, and stinging/burning (scale: 0 = none to 3 = severe). On the final study visit, the participants completed a Cosmetic Acceptability Questionnaire. Adverse events were recorded at each study visit. A total of 144 participants were enrolled and 130 completed the studies (study 1, n = 66; study 2, n = 64). The lotion formulation was non-inferior to the cream for the success rates and tolerability assessments in both studies. The frequency distributions of worst scores of either 0 (none) or 1 (mild) (study 1; study 2) for adapalene lotion were erythema (98.5%; 40.7%), scaling (100%; 73.5%), dryness (100%; 68.8%), and stinging/burning (98.5%; 100%). The most common treatment-related adverse event was dryness (study 1, cream 2.7% [2 of 75] and lotion 4.0% [3/75]); study 2, cream 2.9% [2 of 69] and lotion 4.3% [3 of 69]. Both the adapalene 0.1% cream and 0.1% lotion formulations were well tolerated and acceptable to the study participants. The adapalene 0.1% lotion provides clinicians with a retinoid for the treatment of acne in a lotion formulation.

PubMed, Feb 1, 2011

Objective: To compare the functional stability of Cetaphil UVA/UVB Defense SPF 50 as measured by ... more Objective: To compare the functional stability of Cetaphil UVA/UVB Defense SPF 50 as measured by its ultraviolet B sun protection factor (UVB-SPF) and ultraviolet A protection factor (UVA-PF) values following exposure to natural sunlight versus the UVB-SPF and UVA-PF values of unexposed product. Methods: These two randomized, controlled, evaluator-blinded, single-center trials were conducted according to the methods outlined in the 2007 Proposed Amendment to the Final Monograph, “Sunscreen Drug Products for Over-the-Counter Human Use.” Sunscreen samples were applied to glass plates and exposed to ultraviolet radiation in the form of natural sunlight in four minimal erythemal doses (MED) ranging from 2–6 MED (42–36 mJ/cm2). Three test sites were identified on the back of each study subject. Exposed sunscreen (one of four doses), unexposed sunscreen, and a UVB-SPF 15 control sunscreen were applied to the three test sites in a randomized fashion, followed by UV irradiation of incremental doses. Erythema and pigment darkening responses were assessed immediately following UV exposure and again 16–24 hours (erythema) or three to 24 hours (pigment darkening) after exposure. UVB-SPF and UVA-PF values were calculated for the exposed and unexposed samples. Results: The calculated UVB-SPF and UVA-PF values for all test samples (exposed and unexposed) were >50 and >9, respectively, which were greater than the stated UVB-SPF and UVA-PF values on the product label. No differences were observed between the exposed and unexposed samples in UVB-SPF or UVA-PF. Conclusion: The UVA and UVB protection using standard evaluation techniques of Cetaphil UVA/UVB Defense SPF 50 remains stable despite exposure of the sunscreen to natural sunlight containing UVB ranging from 2–16 MED (41–336 mJ/cm2) and coexistent UVA.

PubMed, 2009

Topical corticosteroids are widely used in the treatment of psoriasis. This study was conducted t... more Topical corticosteroids are widely used in the treatment of psoriasis. This study was conducted to compare the efficacy and safety of clobetasol propionate (CP) 0.005% spray to calcipotriene 0.005%-betamethasome diproprionate 0.064% (C-BD) ointment in patients with moderate to severe plaque psoriasis. Assessments were made at baseline, week 2, week 4 (end of treatment) and week 8 (4 weeks posttreatment). An assessment for Overall Disease Severity (ODS) found that 75% of CP spray-treated patients achieved a rating of clear or almost clear after 4 weeks of treatment compared to 45% of C-BD ointment-treated patients (P=.003). Adverse events were reported by less than one-third of patients from each treatment group (31% for CP spray and 33% for C-BD ointment).

PubMed, May 1, 2011

Background: A gel combination treatment containing a retinoid (adapalene 0.1%) and an antimicrobi... more Background: A gel combination treatment containing a retinoid (adapalene 0.1%) and an antimicrobial (benzoyl peroxide 2.5%) has been shown to be an effective treatment for acne vulgaris, addressing three of the four pathogenic factors (hyperkeratinization, Propionibacterium acnes proliferation, inflammation) without contributing to the incidence of Propionibacterium acnes antibiotic resistance as neither the retinoid nor benzoyl peroxide creates selective pressure for resistance. Objective: To evaluate the effectiveness of an adapalene-benzoyl peroxide gel combination in reducing antibiotic-sensitive and resistant strains of Propionibacterium acnes on the facial skin of volunteers. Methods: This four-week, open-label, single-center study included 30 healthy adults with high facial Propionibacterium acnes populations [>10(4) colony-forming units per square centimeter of skin (CFU/cm(2))] and presence of subpopulations resistant to erythromycin, tetracycline, and clindamycin. The gel was applied once daily to the forehead. Cultures for total and antibiotic-resistant Propionibacterium acnes were obtained from the forehead area at screening, Baseline, Week 2, and Week 4. Results: Total Propionibacterium acnes counts decreased by 1.1 log(10) CFU/cm(2) after two weeks of treatment, and by 1.6 log10 CFU/cm(2) after four weeks. All subjects had strains resistant to each of the five antibiotics at baseline. Mean counts of erythromycin and clindamycin resistant Propionibacterium acnes were high at baseline (5.37 and 5.28 log(10) CFU/cm(2), respectively) and decreased by ≥2.1 log(10) by Week 4 (P<0.001). Mean counts of strains resistant to tetracyclines were lower at baseline (3.8 to 4.2 CFU/cm(2)) and decreased by 1.9 (tetracycline), 2.4 (minocycline), and 1.3 (doxycycline) log(10) CFU/cm(2) by Week 4 (P<0.001). Limitations: Although limited in scope, the results of the present study demonstrate that the fixed-dose combination gel containing adapalene 0.1% and benzoyl peroxide 2.5% effectively inhibited both antibiotic-susceptible and antibiotic-resistant Propionibacterium acnes. In addition to reducing population densities, therapy with adapalene-benzoyl peroxide eradicated some resistant strains entirely in some individual subjects. Conclusion: Topical adapalene-benzoyl peroxide gel effectively reduced skin colonization by antibiotic-sensitive and antibiotic-resistant Propionibacterium acnes after four weeks. This trial was registered with ClinicalTrials.gov (http://clinicaltrials.gov/), registry number NCT00907101.

Journal of The American Academy of Dermatology, Jun 1, 2010

Background: Melasma is often recalcitrant to treatment. Triple combination (TC) cream is an effec... more Background: Melasma is often recalcitrant to treatment. Triple combination (TC) cream is an effective and approved treatment for melasma. Objective: We sought to determine the efficacy and safety of continuous therapy followed by a maintenance treatment regimen during a period of 24 weeks with a TC cream containing hydroquinone 4%, tretinoin 0.05%, and fluocinolone acetonide 0.01%. Methods: Seventy patients with melasma were treated with a TC cream daily for 12 weeks, after which, if clear or almost clear, they applied the cream twice per week for 12 more weeks. For patients who were not clear or almost clear after 12 weeks, daily treatment was continued. Results: In all, 25 patients completing the study per protocol were treated daily for 24 weeks (cohort A); 6 patients were treated daily for 12 weeks followed by 12 weeks of maintenance therapy (cohort B); and 21 patients were treated daily for 12 weeks, relapsed during the maintenance phase, and returned to daily dosing (cohort C). Pigmentation was significantly reduced at weeks 12 and 24 and global melasma severity improved at week 24 in cohorts A and C compared with baseline. Adverse events occurred in 53% of patients and were primarily mild in severity. Limitations: This was an open-label trial. Conclusion: About half of patients treated with a TC cream for melasma were able to begin maintenance therapy twice per week after 12 weeks; however, relapses occurred in most of these patients, requiring resumption of daily therapy. The cream is safe in the treatment of moderate to severe melasma for up to 24 weeks when used intermittently or continuously. Significant reductions in melasma severity scores were seen at weeks 12 and 24 when compared with baseline scores in all evaluable study groups (

Dermatologic Surgery, Feb 1, 2011

BACKGROUND Triple combination (TC) cream is a stable combination of fluocinolone acetonide 0.01%,... more BACKGROUND Triple combination (TC) cream is a stable combination of fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05% and is currently the only hydroquinone-containing drug approved by the Food and Drug Administration for the treatment of melasma. OBJECTIVE To evaluate the safety and efficacy of TC cream when used sequentially with intense pulsed light (IPL) treatments in patients with moderate to severe melasma. MATERIALS & METHODS This was a 10-week, split-face study in which 56 patients with symmetrical melasma lesions were treated with TC cream on one side of the face and an inactive control cream on the other side of the face. Patients also had two IPL treatments at weeks 2 and 6. (Topical treatment was suspended during IPL treatments 7 1 day.) RESULTS Melasma severity was significantly less with TC cream and IPL than with inactive cream and IPL at weeks 6 (p = .007) and 10 (p = .002). Improvement in melasma was greater with TC cream and IPL than with inactive cream and IPL according to investigator and patient evaluations at weeks 6 and 10 (po.001 for both time points). Treatment with TC cream and IPL was well tolerated. CONCLUSION The results of this study suggest that TC cream and IPL treatment is an effective and safe treatment option for patients with melasma.

PubMed, Oct 1, 2011

High-potency topical corticosteroids are the cornerstone of psoriasis therapy. Although highly ef... more High-potency topical corticosteroids are the cornerstone of psoriasis therapy. Although highly effective, long-term use of topical steroids can cause adverse side effects. Additionally, steroids alone do not address the multiple pathophysiologic factors that cause the disease. Psoriasis regimens that utilize high-potency steroids combined with nonsteroid-containing products such as vitamin D analogs have been used for many years to manage the disease, not only for the short-term treatment of the disease but also for long-term treatment to minimize the recurrence of symptoms. We report an open-label, multicenter study designed to evaluate a weekday/ weekend treatment regimen involving calcitriol ointment 3 microg/g and clobetasol propionate spray 0.05% for moderate plaque psoriasis. Participants applied calcitriol ointment 3 microg/g twice daily on the weekdays and clobetasol propionate spray 0.05% twice daily on the weekends for up to 4 weeks. Participants were evaluated at baseline, week 2, and week 4. The results of this study demonstrate that a 4-week regimen of calcitriol ointment 3 microg/g treatment on weekdays and clobetasol propionate spray 0.05% on weekends is effective and well-tolerated for the treatment of moderate plaque psoriasis.

PubMed, Jul 1, 2011

Psoriasis is a chronic condition with serious quality-of-life ramifications. Dermatologists seek ... more Psoriasis is a chronic condition with serious quality-of-life ramifications. Dermatologists seek alternative treatments of patients with plaque psoriasis that provide both efficacy and safety while minimizing exposure to high-potency steroids that can have adverse effects following long-term use. We report an open-label, multicenter study designed to evaluate a morning/evening (AM/PM) treatment regimen involving clobetasol propionate spray 0.05% and calcitriol ointment 3 microg/g for moderate plaque psoriasis. Participants applied clobetasol propionate spray 0.05% in the morning and calcitriol ointment 3 microg/g in the evening for up to 4 weeks. Participants were evaluated at baseline, week 2, and week 4. The results of this study indicate that a 4-week regimen of clobetasol propionate spray 0.05% treatment in the morning and calcitriol ointment 3 microg/g in the evening is efficacious and without unexpected safety issues for the management of moderate plaque psoriasis.

Melanoma Research, Jun 1, 2010

Journal of Drugs in Dermatology, Jun 1, 2008

A variety of topical retinoids is available for the treatment of acne vulgaris. Selection of the ... more A variety of topical retinoids is available for the treatment of acne vulgaris. Selection of the appropriate treatment depends not only on efficacy but also on how well the patient can tolerate different formulations. The goal of this study was to evaluate the efficacy and tolerability of daily adapalene 0.1% gel compared to daily tazarotene 0.1% cream and to demonstrate the noninferiority of adapalene 0.1% gel when compared to tazarotene 0.1% cream in treating acne. This represents 2 arms of a 3-arm study. Subjects 12 to 35 years of age with acne vulgaris (N=202) participated in a 12-week, randomized, evaluator-blinded study of once-daily therapy with adapalene 0.1% gel versus tazarotene 0.1% cream. The primary measure of efficacy was the reduction in total lesion counts posttreatment. Subjects treated with adapalene 0.1% gel achieved similar reductions in total lesion counts at week 12 compared to the subjects treated with the tazarotene cream, which demonstrates the noninferiority of adapalene treatment compared to tazarotene (median difference: -1.18%; lower confidence limit [LCL]: -9.26). At week 2, the number of patients that experienced erythema and scaling with tazarotene 0.1% cream was greater when compared to adapalene 0.1% gel and statistically significant. By week 12, the percentage of subjects reporting cutaneous irritation had returned to or near baseline levels and was similar between treatment arms for all parameters assessed. Adapalene gel was associated with fewer treatment-related adverse events than tazarotene cream (36% versus 58%, respectively), and less than half as many adverse events that were &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;definitely&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; related to study treatment than tazarotene cream (20% versus 45%, respectively). Daily therapy with adapalene 0.1% gel was shown to be noninferior to tazarotene 0.1% cream in total acne lesion reductions, and during initial stages of treatment, demonstrated better tolerability with respect to erythema and scaling.

PubMed, Feb 1, 2011

Background: Psoriasis is a hyperproliferative and inflammatory skin disorder that affects roughly... more Background: Psoriasis is a hyperproliferative and inflammatory skin disorder that affects roughly 2 percent of the worldwide population. Clobetasol propionate is the most common corticosteroid used to treat moderate-to-severe psoriasis but the potential for side effects limits its long-term use. Topical vitamin D, which is used to treat mild-to-moderate psoriasis, has been shown to be safe when used daily for up to 52 weeks. To date, very few studies exist evaluating the use of clobetasol propionate in a regimen with calcitriol to manage moderate-to-severe disease over time. Objectives: To evaluate the efficacy and assess safety of a regimen of sequential topical treatments with clobetasol propionate 0.05% spray for up to four weeks followed by calcitriol 3 μg/g ointment for eight weeks in the management of moderate-to-severe plaque psoriasis. Methods: This was a multi-center, open-label study in subjects aged 18-80 years with moderate-to-severe plaque psoriasis at baseline. Subjects applied clobetasol propionate 0.05% spray twice daily for up to four weeks. At the end of four weeks, if the subject's overall disease severity (ODS) was assessed as clear, almost clear, mild or moderate, subjects started treatment with calcitriol 3 μg/g ointment twice daily. Twice-daily treatment with calcitriol 3 μg/g ointment continued for eight weeks (until week 12) or unless the subject's ODS was assessed as severe or returned to the baseline score, at which time it was discontinued. Subjects were evaluated at baseline and at weeks 2, 4, 8 and 12. Results: Of the 305 subjects enrolled, 170 subjects completed the full 12-week study with no major protocol deviations and comprised the per-protocol (PP) study population. Treatment success, defined as at least one grade improvement in ODS at week 12 compared to baseline, was achieved in 84.1 percent of subjects. The percent body surface area affected (% BSA) decreased from 7.1 percent at baseline to 3.9 percent at week 12 (P<0.001). The sequential treatment regimen was well tolerated with no unexpected adverse events. Most reported adverse events and cutaneous irritations were mild in severity. Conclusions: The results of this study indicate that the 12-week regimen of clobetasol propionate 0.05% spray treatment for four weeks immediately followed by an eight-week treatment phase with calcitriol 3 μg/g ointment is efficacious and safe for the management of moderate-to-severe plaque psoriasis.

Journal of Cosmetic and Laser Therapy, Mar 14, 2011

This report documents the optical characteristics of a number of photodynamic therapy (PDT) light... more This report documents the optical characteristics of a number of photodynamic therapy (PDT) light sources of varied types, measured and indexed relative to estimated effectiveness for activation of the PDT chromaphore protoporphyrin IX (PpIX). PDT sources in use at several clinics, including intense pulsed light (IPL) sources, lasers, and continuous wave (CW) light sources, were spectroradiometrically measured and indexed relative to their overlap to an absorption spectrum of PpIX. The sources were highly disparate, varying in power from irradiance in the mW/cm(2) range for the CW sources up to ∼30 J/cm(2) per flash for the IPL sources. Our PpIX Index ranged by a factor of nearly 100 (0.008-0.630) in estimated PpIX PDT effectiveness following the distinct spectral characteristics of the light sources surveyed. Application of this PpIX Index, tempered with an understanding of the biology of the lesion being treated and effective spectrum of the light source reaching the lesion requiring therapy, provides a rational algorithm to approximate equivalent light doses prior to clinical protocols to establish equivalent patient outcomes employing alternative PDT light sources.

Journal of The American Academy of Dermatology, 2011

Background: The Melasma Area and Severity Index (MASI), the most commonly used outcome measure fo... more Background: The Melasma Area and Severity Index (MASI), the most commonly used outcome measure for melasma, has not been validated. Objective: We sought to determine the reliability and validity of the MASI. Methods: After standardized training, 6 raters independently rated 21 patients with mild to severe melasma once daily over a period of 2 days to determine intrarater and interrater reliability. Validation was performed by comparing the MASI with the melasma severity scale. The darkness component of the MASI was validated by comparing it with the difference between mexameter scores for affected versus adjacent normal-appearing skin. The area component of the MASI was validated by comparing it with the area of each section of the face determined by computer-based measurement software. Results: The MASI score showed good reliability within and between raters and was found to be valid when compared with the melasma severity scale, mexameter scores, and area measurements. Homogeneity assessment by raters showed the least agreement and can be removed from the MASI score without any loss of reliability. Limitations: Patients were limited to Hispanic, African, and Asian backgrounds. Conclusion: The MASI is a reliable measure of melasma severity. Area of involvement and darkness are sufficient for accurate measurement of the severity of melasma and homogeneity can be eliminated.

Cutis, May 1, 2011

The purpose of this study was to assess the cosmetic appearance of commonly marketed facial cosme... more The purpose of this study was to assess the cosmetic appearance of commonly marketed facial cosmetics when used after the application of metronidazole gel 1%. An observational. open-label, single-site study was conducted with women (N=30) aged 20 to 75 years and diagnosed with moderate papulopustular rosacea (investigator global severity score of 3). After cleansing the face with a gentle skin cleanser, participants applied metronidazole gel 1% once daily before applying their usual facial foundation. Two surveys were conducted: (1) investigator assessment of cosmetic appearance; and (2) participant assessment of cosmetic appearance. The investigator also evaluated erythema, disease severity, and tolerability at baseline and week 2. Adverse events were collected. The 28 per-protocol (PP) participants had a mean age (standard deviation [SD]) of 54.0 (10.3) years and a mean duration (SD) of rosacea of 15.4 (13.2) years. The median response score for both the investigator and participant assessments of cosmetic appearance was 10 (best) for each survey question. Signs and symptoms of rosacea did not increase with use of metronidazole gel 1% and the participants&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; selected cosmetic regimen. At baseline all 28 participants were classified as having moderate erythema. At week 2, 18 (64%) participants were classified as having moderate erythema and 10 (36%) mild. At baseline all 28 (100%) participants were classified as having moderate rosacea according to the investigator global severity score. At week 2, 10 (36%) participants were classified as mild and 18 (64%) moderate. In addition, few participants reported cutaneous irritation during the study. At week 2, 10 participants had dryness, 2 had itching, 8 had scaling, and 2 had stinging/burning. According to surveys completed by the investigator and the participants themselves, most participants had a good cosmetic appearance with their facial foundation cosmetics that were applied after metronidazole gel 1%. The use of various cosmetic regimens after application of metronidazole gel 1% did not cause rosacea symptoms to worsen and treatment was well-tolerated.

Journal of the American Academy of Dermatology, 2011

Background: The Melasma Area and Severity Index (MASI), the most commonly used outcome measure fo... more Background: The Melasma Area and Severity Index (MASI), the most commonly used outcome measure for melasma, has not been validated. Objective: We sought to determine the reliability and validity of the MASI. Methods: After standardized training, 6 raters independently rated 21 patients with mild to severe melasma once daily over a period of 2 days to determine intrarater and interrater reliability. Validation was performed by comparing the MASI with the melasma severity scale. The darkness component of the MASI was validated by comparing it with the difference between mexameter scores for affected versus adjacent normal-appearing skin. The area component of the MASI was validated by comparing it with the area of each section of the face determined by computer-based measurement software. Results: The MASI score showed good reliability within and between raters and was found to be valid when compared with the melasma severity scale, mexameter scores, and area measurements. Homogeneity assessment by raters showed the least agreement and can be removed from the MASI score without any loss of reliability. Limitations: Patients were limited to Hispanic, African, and Asian backgrounds. Conclusion: The MASI is a reliable measure of melasma severity. Area of involvement and darkness are sufficient for accurate measurement of the severity of melasma and homogeneity can be eliminated.