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Papers by Bhushan Hardas

Research paper thumbnail of Topical botulinum toxin type A

Topical botulinum toxin type A

Elsevier eBooks, 2018

Research paper thumbnail of A Validated Grading Scale for Forehead Lines

Dermatologic Surgery, Nov 1, 2008

BACKGROUND As with other facial wrinkles, the gradual loss and disorganization of collagen fibers... more BACKGROUND As with other facial wrinkles, the gradual loss and disorganization of collagen fibers and elastin, connective tissues that provide underlying support for skin, cause horizontal forehead rhytides in large part. OBJECTIVES To develop the Forehead Lines Grading Scale for objective quantification of horizontal forehead rhytides at rest and with expression and to establish the reliability of this photonumeric scale for clinical research and practice. MATERIALS AND METHODS The Forehead Lines Grading Scale is a 5-point photonumeric rating scale that was developed to objectively quantify resting (static) and hyperkinetic (dynamic) forehead lines. Inter-and intrarater variability was assessed by computing intraclass correlation coefficients. RESULTS The agreement between the experts was highly significant. Bubble plots (bivariate scatter plots) demonstrated linearity in judgment by the experts. CONCLUSION The 5-point photonumeric scale generated spans the severity of forehead lines for which patients commonly seek correction. The scale is well stratified for consistent rating.

Research paper thumbnail of A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis

A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis

PubMed, Nov 1, 2011

Objective: Naftifine HCl 2% cream (NAFT-2) is a topical allylamine antifungal agent under develop... more Objective: Naftifine HCl 2% cream (NAFT-2) is a topical allylamine antifungal agent under development in the United States. This randomized, double-blind, vehicle-controlled, phase 3 trial evaluated the efficacy and safety of two weeks of NAFT-2 treatment in subjects with tinea pedis. Naftifine 1% cream (NAFT-1) treatment for four weeks and vehicle were also evaluated as a positive control. Methods: 709 subjects were randomly assigned 2:1:2:1 to one of four treatment groups: (i) NAFT-2 (n= 235), (ii) two-week vehicle (n=118), (iii) NAFT-1 (n=237), or (iv) four-week vehicle (n=119). Efficacy was evaluated at baseline, week 2, week 4, and week 6 and consisted of mycology determination (KOH and dermatophyte culture) and scoring of clinical symptom severity (erythema, scaling, and pruritus). Efficacy was only analyzed in 425 subjects with positive baseline dermatophyte culture. Safety was evaluated by adverse events (AE) and laboratory values in 707 subjects. Results: At week 6, NAFT-2 subjects achieved 18 percent complete cure rate, 67 percent mycological cure rate, 57 percent treatment effectiveness, 22 percent clinical cure rate, and 78 percent clinical success rate compared to respective vehicle rates of seven percent (one-sided, P<0.01), 21 percent (P<0.001), 20 percent (P<0.001), 11 percent (P=0.04) and 49 percent (P<0.001). Week 6 efficacy responses in NAFT-1-treated subjects were significantly higher than vehicle subjects and almost identical to NAFT-2 subjects. Mycological cure and clinical response rates in both NAFT-2 and NAFT-1 increased from week 2 to week 6. Treatment-related AEs occurred in five percent of NAFT-2 subjects, seven percent of vehicle subjects, four percent of NAFT-1 subjects and eight percent of vehicle subjects. The most common AEs for all groups were application site pruritus and skin irritation. Conclusion: Topical NAFT-2 for two weeks is safe and provides significantly superior antifungal treatment than vehicle in tinea pedis subjects. NAFT-2 produces equivalent efficacy responses to four weeks of NAFT-1 treatment. The fungicidal activity of naftifine continues to increase for at least one month after treatment is completed. (Clinical Trials Identification Numbe=NCT00750139). J Drugs Dermatol. 2011;10(11):1282-1288.

Research paper thumbnail of Efficacy and safety of naftifine HCl Gel 2% in the treatment of interdigital and moccasin type tinea pedis: pooled results from two multicenter, randomized, double-blind, vehicle-controlled trials

Efficacy and safety of naftifine HCl Gel 2% in the treatment of interdigital and moccasin type tinea pedis: pooled results from two multicenter, randomized, double-blind, vehicle-controlled trials

PubMed, Aug 1, 2013

Background: Tinea pedis is the most common chronic fungal infection. Naftifine hydrochloride is a... more Background: Tinea pedis is the most common chronic fungal infection. Naftifine hydrochloride is a topical antifungal of the allylamine class, displaying fungicidal activity and clinically significant anti-bacterial and anti-inflammatory effects. Objective: To evaluate the efficacy and safety of two-weeks once daily application of naftifine gel 2% in the treatment of tinea pedis. Methods: At baseline, 1715 subjects were randomly assigned 2:1 to naftifine gel 2% (n=1144) and vehicle (n=571). Efficacy consisting of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity was evaluated at baseline and weeks 2, 4, and 6. Efficacy was analyzed in 1174 subjects (n=782, naftifine; n=392, vehicle) with a positive baseline dermatophyte culture and KOH for whom week 6 assessments were available. Safety was evaluated by adverse events (AE) and laboratory values in 1714 subjects (n=1143, naftifine; n=571, vehicle). Results: Subjects treated with naftifine gel 2% for interdigital-type tinea pedis demonstrated greater improvement from baseline for complete cure (P=0.001), mycological cure (P<0.0001), and treatment effectiveness (P<0.0001) as early as 2 weeks when compared to vehicle; however the highest response rates were seen 4-weeks post treatment (P<0.0001, for all endpoints). Statistically significant results for complete cure, mycological cure, and treatment effectiveness (P<0.0001, for all endpoints) were also seen at week 6 among subjects with moccasin-type tinea pedis. Treatment related adverse events were minimal. Conclusions: Treatment with naftifine gel 2% applied once daily for two weeks is well-tolerated and is effective in treating both interdigital-type and moccasin-type tinea pedis. Continuous improvement is observed from the end of treatment to four-weeks after treatment cessation among key outcome measures (complete cure, mycological cure, and treatment effectiveness) as well as clinical signs and symptoms (erythema, scaling, and pruritus)

Research paper thumbnail of Detection and relevance of naftifine hydrochloride in the stratum corneum up to four weeks following the last application of naftifine cream and gel, 2%

Detection and relevance of naftifine hydrochloride in the stratum corneum up to four weeks following the last application of naftifine cream and gel, 2%

PubMed, Sep 1, 2013

Background: Two-week treatment using naftifine cream or gel, 2% has been shown to be efficacious ... more Background: Two-week treatment using naftifine cream or gel, 2% has been shown to be efficacious in subjects with Tinea pedis and/or Tinea cruris, and in most cases, continued improvement has been observed following cessation of treatment for up to four weeks. One possible explanation for continuous post-treatment improvement is drug-levels remaining in the stratum corneum (SC) as a function of time. Objective: The objective is to use tape stripping methodology to assess the amount of drug available in the SC over a 28 day period following the last dose. Methods: This was an open-label, single-exposure study on subjects comparing the amount of drug that was absorbed into the SC following topical application for 2-weeks. Twelve subjects were dosed daily (6 with naftifine cream, 2% and 6 with naftifine gel, 2%). Subjects had twelve 8 cm2 test application sites demarcated on the upper back. Twenty-five individual sequential strips were obtained from each test site. Of these, 11 sites were dosed once daily with the drug (5.0μL/cm2) for days 1 to 14 and the final site served as the control. On days 15, 29, and 43, a site was stripped to collect the SC in order to process the amount of drug present. Results: Naftifine was present on all tape strip samples collected over the 28 day period following two weeks of application. Furthermore, the most relevant, deeper tape strip sets reflecting the SC, showed potentially clinically relevant presence of naftifine in the skin for 28-days post-treatment. Conclusions: Naftifine was present in the tape strips on all sample collection days up to and including four weeks following the last drug application. These findings help explain the progressive improvement in clinical and mycological response rates during the treatment period and for up to four weeks post-treatment in the clinical trials using naftifine.

Research paper thumbnail of A new proprietary onion extract gel improves the appearance of new scars: a randomized, controlled, blinded-investigator study

PubMed, Jun 1, 2012

Objective: This randomized, controlled, single-blind study evaluated the appearance of new dermal... more Objective: This randomized, controlled, single-blind study evaluated the appearance of new dermal scars after eight weeks of once-daily application of a nonprescription proprietary onion extract gel formulation compared to control (no application scars) in a dermatological surgical setting. Methods: At Visit 1, 44 healthy male and female subjects aged 18 to 70 years gave informed consent, were screened, and enrolled in the study. Two bilateral, 8mm seborrheic keratoses, one on the right and one on the left chest, were surgically removed from each subject. The wounds were photographed at all visits. Two weeks later (Visit 2), each subject was randomly assigned to apply onion extract gel to either the right or left side wound site once daily for eight weeks and no treatment on the opposite wound. The investigator was blinded to which wound was treated. At two, four, and eight weeks after gel application, right and left scars were graded by the investigator and subjects for improvement from baseline in overall appearance, texture, redness, and softness using 4-point ordinal scales (0=no improvement, 1=mild improvement; 2= moderate improvement; 3=significant improvement). Safety was evaluated by adverse events. Results: Six subjects (13.6%) experienced mild stinging that resolved spontaneously. At two weeks, the subjects rated gel-applied scars to be significantly softer than control scars (p=0.014). After four and eight weeks of application, the investigator and subjects rated all appearance variables of the gel-applied scars to be significantly more improved from baseline than control scars (p=0.017 to p<0.01). Conclusion: The new proprietary onion extract gel is safe and significantly improves scar appearance after four weeks of once-daily application.

Research paper thumbnail of Direct Evidence for Homologous Sequences on the Paracentric Regions of Human Chromosome 1

Research paper thumbnail of Assignment of Psoriasin to Human Chromosomal Band 1q21: Coordinate Overexpression of Clustered Genes is Psoriasis

Journal of Investigative Dermatology, Apr 1, 1996

Depa rtlll ents of * Derlll atolob'Y• 11R adi ation O ncology. and :j: HlIlll an Genetics. Uni ve... more Depa rtlll ents of * Derlll atolob'Y• 11R adi ation O ncology. and :j: HlIlll an Genetics. Uni versity of Mi chi gan, Ann Arbor, Mi chiga n. U.S.A. Psoriasin is an abundant low molecular weight protein in k e r a tinocy tes from psoria tic lesions. Because of simila rities ill. gene structure and expression to o ther g e nes on hUlnan chrolnosolnal band 1q21, we hypothesiz ed tha t psoriasin might also map to this region. To test this hypothesis, we identified and used a genomic A. clone (A.9.2) as a probe for fluorescent ill Sitlt hybridization. A.9. 2 detected the 1q21 region in 81 % of 52 chromosomes 1 exalnine d, although it also hybridize d t o acrocentric chromosomes. A.9. 2 DNA yielded poly m e r ase c hain reaction an~plification of a 121-bp sequ e nce colinear with psoria sin eDNA, as did T ~l C proccss of c. pithc li al di.ffc re nti ati o n. is eVO luti o.n arli y an Cie n t and well-co n se rvcd (B ere ltc r-Hahn ('(aI, 1 984). T h e re for e, th e m e hallism b y w h ic h gen es ce n tr al to th is process are regu lated is like ly to b e an cie nt and con se rv e d as we ll. O n e su c h m ech anism might in vo lve the clu sterin g of fun ction all y rc lated gen es, a rec urrent p hc n o m e n o n in eukaryotic as w e ll as pro k a ryo ti c gen o mi c organ izatio n (O hta, 1991). Ev iden cc fo r th e impo rta n ce of gc n e clustering fo r a pp ro pri ate coordin a te ge n c cx press io n is provide d by seve ral h o m eob ox ge n e cluste rs (Ge hrin g , 1 992), th e human j3-likc g lo bin gcn e c luster (To wn es and B e h rin ge r, 1 990) , and th e varia bl e regio ns of th e T-cell rece ptor 'Y ge n e (Lefran c and

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Assessment of Chin Retrusion

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of chin appeara... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of chin appearance before and after chin augmentation in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Chin Retrusion Scale. METHODS The Allergan Chin Retrusion Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 298) completed during 2 sessions occurring 3 weeks apart. RESULTS A difference of $1 point on the scale was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference, 1.07 [0.94-1.20] for clinically different image pairs and 0.51 [0.39-0.63] for not clinically different pairs). Intrarater agreement between the 2 live-subject validation sessions was substantial (mean weighted kappa = 0.79). Interrater agreement was substantial during the second rating session (0.68, primary end point). CONCLUSION The Allergan Chin Retrusion Scale is a validated and reliable scale for physician rating of severity of chin retrusion.

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Evaluation of Facial Fine Lines

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of facial fine ... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of facial fine lines before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Fine Lines Scale. METHODS The Allergan Fine Lines Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live subject validation study (N = 289) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of $1 point was shown to reflect a clinically significant difference (mean [95% CI] absolute score difference, 1.06 [0.92-1.21] for clinically different image pairs and 0.50 [0.38-0.61] for not clinically different pairs). Intrarater agreement between the 2 live subject validation sessions was almost perfect (weighted kappa = 0.85). Interrater agreement was substantial during the second rating session (0.76, primary end point). CONCLUSION The Allergan Fine Lines Scale is a validated and reliable scale for physician rating of severity of superficial fine lines.

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Evaluation of Facial Skin Texture

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of facial skin ... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of facial skin roughness before and after aesthetic treatment in practice and in clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Skin Roughness Scale. METHODS The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 290) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of $1 point was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference 1.09 [0.96-1.23] for clinically different image pairs and 0.53 [0.38-0.67] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (weighted kappa = 0.83). Interrater agreement was almost perfect during the second rating session (0.81, primary end point). CONCLUSION The Allergan Skin Roughness Scale is a validated and reliable scale for physician rating of midface skin roughness.

Research paper thumbnail of Efficacy and Safety of OnabotulinumtoxinA for Moderate-to-Severe Forehead Lines in Subjects with Upper Facial Lines

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Evaluation of Static Horizontal Forehead Lines

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of static foreh... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of static forehead lines before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Forehead Lines Scale. METHODS The Allergan Forehead Lines Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 295) completed during 2 sessions occurring 3 weeks apart. RESULTS A difference of $1 point on the scale was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.06 [0.91-1.21] for clinically different image pairs and 0.38 [0.26-0.51] for not clinically different pairs). Intrarater agreement between the 2 live-subject validation sessions was almost perfect (mean weighted kappa = 0.87). Interrater agreement was almost perfect during the second rating session (0.86, primary end point). CONCLUSION The Allergan Forehead Lines Scale is a validated and reliable scale for physician rating of static horizontal forehead lines.

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Evaluation of Volume Deficit of the Hand

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of hand appeara... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of hand appearance before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Hand Volume Deficit Scale. METHODS The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real-subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 296) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of $1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.12 [0.99-1.26] for clinically different image pairs and 0.45 [0.33-0.57] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.83). Interrater agreement was almost perfect during the second session (0.82, primary end point). CONCLUSION The Allergan Hand Volume Deficit Scale is a validated and reliable scale for physician rating of hand volume deficit.

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Evaluation of Infraorbital Hollows

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of infraorbital... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of infraorbital hollows (i.e., tear troughs) before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Infraorbital Hollows Scale. METHODS The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 297) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of $1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 0.90 [0.79-1.02] for clinically different image pairs and 0.33 [0.19-0.46] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was substantial (mean weighted kappa = 0.79). Interrater agreement was substantial during the second rating session (0.70, primary end point). CONCLUSION The Allergan Infraorbital Hollows Scale is a validated and reliable scale for physician rating severity of hollowing in the infraorbital area.

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Evaluation of Transverse Neck Lines

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of horizontal n... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of horizontal neck lines before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Transverse Neck Lines Scale. METHODS The Allergan Transverse Neck Lines Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject rating validation study (N = 297) completed during 2 sessions occurring 3 weeks apart. RESULTS A difference of $1 point on the scale was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.22 [1.09-1.35] for clinically different image pairs and 0.57 [0.42-0.72] for not clinically different pairs). Intrarater agreement between the 2 live-subject rating validation sessions was substantial (mean weighted kappa = 0.78). Interrater agreement was substantial during the second rating session (0.73, primary end point). CONCLUSION The Allergan Transverse Neck Lines Scale is a validated and reliable scale for rating of severity of neck lines.

Research paper thumbnail of <i>In Vitro</i> Antifungal Activity of Naftifine Hydrochloride against Dermatophytes

Antimicrobial Agents and Chemotherapy, Sep 1, 2013

The incidence of superficial dermatophytoses is high in developed countries, and there remains a ... more The incidence of superficial dermatophytoses is high in developed countries, and there remains a need for effective topical antifungals. In this study, we evaluated the in vitro antifungal activity of naftifine hydrochloride, the active ingredient in naftifine hydrochloride cream and gel 1% and 2%, against dermatophytes. The MICs and minimum fungicidal concentrations (MFCs) of naftifine hydrochloride against 350 clinical strains, including Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Epidermophyton floccosum, and Microsporum canis, were determined using the CLSI methodology. Subsets from this test panel were subsequently tested in a time-kill assay at 0.125؋, 0.25؋, 0.5؋, and 1؋ the MFC for each isolate. CFU counts were performed over a period of 48 h of incubation. Additionally, in order to determine the potential for resistance development, six strains were subjected to 15 serial passages in concentrations higher than the MIC for each strain. MICs were determined following each passage. The MIC range against the dermatophyte isolates tested was 0.015 to 1.0 g/ml, with naftifine hydrochloride being fungicidal against 85% of the Trichophyton species. The time-kill assay showed dose-dependent activity, with the greatest reduction in the numbers of CFU corresponding to the highest drug concentration. There was no increase in MIC for any strains following repeated exposure to naftifine hydrochloride. Naftifine hydrochloride demonstrated potent activity against all dermatophytes tested, and none of the isolates within this test panel demonstrated the potential for the development of resistance. Thus, future clinical studies of naftifine hydrochloride against dermatophytes may be warranted for the treatment of superficial dermatophytoses.

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Evaluation of Volume Deficit of the Temple

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of temple appea... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of temple appearance before and after aesthetic treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Temple Hollowing Scale. METHODS The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 298) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of $1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.1 [0.94-1.26] for clinically different image pairs and 0.67 [0.51-0.83] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.86). Interrater agreement was almost perfect during the second session (0.81, primary endpoint). CONCLUSION The Allergan Temple Hollowing Scale is a validated and reliable scale for physician rating of temple volume deficit.

Research paper thumbnail of Safety and Effectiveness of VYC-15L, a Hyaluronic Acid Filler for Lip and Perioral Enhancement: One-Year Results From a Randomized, Controlled Study

Dermatologic Surgery, Mar 1, 2017

BACKGROUND VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel wit... more BACKGROUND VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine. OBJECTIVE To evaluate the safety and effectiveness of VYC-15L for lip and perioral enhancement versus a nonanimal stabilized HA with lidocaine (Restylane-L; NASHA). METHODS This prospective multicenter study randomized 225 adults with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) to treatment with VYC-15L or NASHA; optional touch-up was administered 30 days later. Subjects were followed for 1 year. The primary effectiveness end point was noninferiority of VYC-15L versus NASHA by mean change in LFS score from baseline to Month 3. RESULTS The primary end point was met. At Month 3, LFS responder rates were 80.3% for VYC-15L versus 70.8% for NASHA. LFS responder rates exceeded 60% through 1 year with VYC-15L. Perioral lines severity improved for 65.4% and 66.2% of VYC-15L subjects at Month 3 and Year 1, respectively. At Month 3, 96.1% and 88.2% of subjects reported improvement in FACE-Q Satisfaction With Lips and Satisfaction With Lip Lines, respectively. Severe injection site responses were reported less frequently with VYC-15L than NASHA. CONCLUSION VYC-15L was safe and effective for lip and perioral enhancement, with treatment effects lasting through 1 year.

Research paper thumbnail of An open-label pilot study of naftifine 1% gel in the treatment of seborrheic dermatitis of the scalp

An open-label pilot study of naftifine 1% gel in the treatment of seborrheic dermatitis of the scalp

PubMed, Apr 1, 2012

Topical antifungal treatment is a mainstay of therapy for Seborrehic Dermatitis (SD). Although th... more Topical antifungal treatment is a mainstay of therapy for Seborrehic Dermatitis (SD). Although the amidazole and ciclopyridine antifungals have been extensively studied, few clinical efficacy data are available for topical allylamine therapy in SD. The objective of this open-label exploratory study was to evaluate the efficacy and safety of natifine HCl 1% gel applied twice daily for 4 weeks, as topical treatment of moderate SD of the scalp. Nine subjects (5 men, 4 women) with a mean age of 56 (33-81) years with SD of the scalp were enrolled and made 4 visits to the site. At Visit 1 (Week 0), subjects were screened, enrolled, baseline efficacy data were obtained, and treatment was initiated. Subjects returned at Week 2, Week 4 (end of treatment), and Week 6 for efficacy and safety assessments. Efficacy was evaluated by changes from baseline in investigator-rated scores on 0-5-grade scales: (1) SD Global Evaluation Scale (SDGES), (2) Erythema Severity Scale, (3) Scaling Severity Scale, (4) % Scalp Involvement Scale, and subject-rated scores on the (4) Itching Severity Scale, and (5) Global Improvement Scale, where 0=none and 5=most severe. Mean severity scores for the SDGES and % Scalp Involvement scales progressively declined (improved) 66% and 54% from respective baseline levels at Week 6. Mean erythema rating decreased 38% from baseline and scaling decreased 50% from baseline by Weeks 4 and 6. Itching improved in 5 of 9 (56%) subjects by the end of treatment. A total of 8 of 9 (89%) subjects rated their symptoms as improved from baseline at the end of treatment and Week 6. There were no treatment-related adverse events during the study. These results suggest that naftifine 1% gel applied twice daily for 4 weeks is effective and safe topical treatment for moderate SD of the scalp.

Research paper thumbnail of Topical botulinum toxin type A

Topical botulinum toxin type A

Elsevier eBooks, 2018

Research paper thumbnail of A Validated Grading Scale for Forehead Lines

Dermatologic Surgery, Nov 1, 2008

BACKGROUND As with other facial wrinkles, the gradual loss and disorganization of collagen fibers... more BACKGROUND As with other facial wrinkles, the gradual loss and disorganization of collagen fibers and elastin, connective tissues that provide underlying support for skin, cause horizontal forehead rhytides in large part. OBJECTIVES To develop the Forehead Lines Grading Scale for objective quantification of horizontal forehead rhytides at rest and with expression and to establish the reliability of this photonumeric scale for clinical research and practice. MATERIALS AND METHODS The Forehead Lines Grading Scale is a 5-point photonumeric rating scale that was developed to objectively quantify resting (static) and hyperkinetic (dynamic) forehead lines. Inter-and intrarater variability was assessed by computing intraclass correlation coefficients. RESULTS The agreement between the experts was highly significant. Bubble plots (bivariate scatter plots) demonstrated linearity in judgment by the experts. CONCLUSION The 5-point photonumeric scale generated spans the severity of forehead lines for which patients commonly seek correction. The scale is well stratified for consistent rating.

Research paper thumbnail of A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis

A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis

PubMed, Nov 1, 2011

Objective: Naftifine HCl 2% cream (NAFT-2) is a topical allylamine antifungal agent under develop... more Objective: Naftifine HCl 2% cream (NAFT-2) is a topical allylamine antifungal agent under development in the United States. This randomized, double-blind, vehicle-controlled, phase 3 trial evaluated the efficacy and safety of two weeks of NAFT-2 treatment in subjects with tinea pedis. Naftifine 1% cream (NAFT-1) treatment for four weeks and vehicle were also evaluated as a positive control. Methods: 709 subjects were randomly assigned 2:1:2:1 to one of four treatment groups: (i) NAFT-2 (n= 235), (ii) two-week vehicle (n=118), (iii) NAFT-1 (n=237), or (iv) four-week vehicle (n=119). Efficacy was evaluated at baseline, week 2, week 4, and week 6 and consisted of mycology determination (KOH and dermatophyte culture) and scoring of clinical symptom severity (erythema, scaling, and pruritus). Efficacy was only analyzed in 425 subjects with positive baseline dermatophyte culture. Safety was evaluated by adverse events (AE) and laboratory values in 707 subjects. Results: At week 6, NAFT-2 subjects achieved 18 percent complete cure rate, 67 percent mycological cure rate, 57 percent treatment effectiveness, 22 percent clinical cure rate, and 78 percent clinical success rate compared to respective vehicle rates of seven percent (one-sided, P<0.01), 21 percent (P<0.001), 20 percent (P<0.001), 11 percent (P=0.04) and 49 percent (P<0.001). Week 6 efficacy responses in NAFT-1-treated subjects were significantly higher than vehicle subjects and almost identical to NAFT-2 subjects. Mycological cure and clinical response rates in both NAFT-2 and NAFT-1 increased from week 2 to week 6. Treatment-related AEs occurred in five percent of NAFT-2 subjects, seven percent of vehicle subjects, four percent of NAFT-1 subjects and eight percent of vehicle subjects. The most common AEs for all groups were application site pruritus and skin irritation. Conclusion: Topical NAFT-2 for two weeks is safe and provides significantly superior antifungal treatment than vehicle in tinea pedis subjects. NAFT-2 produces equivalent efficacy responses to four weeks of NAFT-1 treatment. The fungicidal activity of naftifine continues to increase for at least one month after treatment is completed. (Clinical Trials Identification Numbe=NCT00750139). J Drugs Dermatol. 2011;10(11):1282-1288.

Research paper thumbnail of Efficacy and safety of naftifine HCl Gel 2% in the treatment of interdigital and moccasin type tinea pedis: pooled results from two multicenter, randomized, double-blind, vehicle-controlled trials

Efficacy and safety of naftifine HCl Gel 2% in the treatment of interdigital and moccasin type tinea pedis: pooled results from two multicenter, randomized, double-blind, vehicle-controlled trials

PubMed, Aug 1, 2013

Background: Tinea pedis is the most common chronic fungal infection. Naftifine hydrochloride is a... more Background: Tinea pedis is the most common chronic fungal infection. Naftifine hydrochloride is a topical antifungal of the allylamine class, displaying fungicidal activity and clinically significant anti-bacterial and anti-inflammatory effects. Objective: To evaluate the efficacy and safety of two-weeks once daily application of naftifine gel 2% in the treatment of tinea pedis. Methods: At baseline, 1715 subjects were randomly assigned 2:1 to naftifine gel 2% (n=1144) and vehicle (n=571). Efficacy consisting of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity was evaluated at baseline and weeks 2, 4, and 6. Efficacy was analyzed in 1174 subjects (n=782, naftifine; n=392, vehicle) with a positive baseline dermatophyte culture and KOH for whom week 6 assessments were available. Safety was evaluated by adverse events (AE) and laboratory values in 1714 subjects (n=1143, naftifine; n=571, vehicle). Results: Subjects treated with naftifine gel 2% for interdigital-type tinea pedis demonstrated greater improvement from baseline for complete cure (P=0.001), mycological cure (P<0.0001), and treatment effectiveness (P<0.0001) as early as 2 weeks when compared to vehicle; however the highest response rates were seen 4-weeks post treatment (P<0.0001, for all endpoints). Statistically significant results for complete cure, mycological cure, and treatment effectiveness (P<0.0001, for all endpoints) were also seen at week 6 among subjects with moccasin-type tinea pedis. Treatment related adverse events were minimal. Conclusions: Treatment with naftifine gel 2% applied once daily for two weeks is well-tolerated and is effective in treating both interdigital-type and moccasin-type tinea pedis. Continuous improvement is observed from the end of treatment to four-weeks after treatment cessation among key outcome measures (complete cure, mycological cure, and treatment effectiveness) as well as clinical signs and symptoms (erythema, scaling, and pruritus)

Research paper thumbnail of Detection and relevance of naftifine hydrochloride in the stratum corneum up to four weeks following the last application of naftifine cream and gel, 2%

Detection and relevance of naftifine hydrochloride in the stratum corneum up to four weeks following the last application of naftifine cream and gel, 2%

PubMed, Sep 1, 2013

Background: Two-week treatment using naftifine cream or gel, 2% has been shown to be efficacious ... more Background: Two-week treatment using naftifine cream or gel, 2% has been shown to be efficacious in subjects with Tinea pedis and/or Tinea cruris, and in most cases, continued improvement has been observed following cessation of treatment for up to four weeks. One possible explanation for continuous post-treatment improvement is drug-levels remaining in the stratum corneum (SC) as a function of time. Objective: The objective is to use tape stripping methodology to assess the amount of drug available in the SC over a 28 day period following the last dose. Methods: This was an open-label, single-exposure study on subjects comparing the amount of drug that was absorbed into the SC following topical application for 2-weeks. Twelve subjects were dosed daily (6 with naftifine cream, 2% and 6 with naftifine gel, 2%). Subjects had twelve 8 cm2 test application sites demarcated on the upper back. Twenty-five individual sequential strips were obtained from each test site. Of these, 11 sites were dosed once daily with the drug (5.0μL/cm2) for days 1 to 14 and the final site served as the control. On days 15, 29, and 43, a site was stripped to collect the SC in order to process the amount of drug present. Results: Naftifine was present on all tape strip samples collected over the 28 day period following two weeks of application. Furthermore, the most relevant, deeper tape strip sets reflecting the SC, showed potentially clinically relevant presence of naftifine in the skin for 28-days post-treatment. Conclusions: Naftifine was present in the tape strips on all sample collection days up to and including four weeks following the last drug application. These findings help explain the progressive improvement in clinical and mycological response rates during the treatment period and for up to four weeks post-treatment in the clinical trials using naftifine.

Research paper thumbnail of A new proprietary onion extract gel improves the appearance of new scars: a randomized, controlled, blinded-investigator study

PubMed, Jun 1, 2012

Objective: This randomized, controlled, single-blind study evaluated the appearance of new dermal... more Objective: This randomized, controlled, single-blind study evaluated the appearance of new dermal scars after eight weeks of once-daily application of a nonprescription proprietary onion extract gel formulation compared to control (no application scars) in a dermatological surgical setting. Methods: At Visit 1, 44 healthy male and female subjects aged 18 to 70 years gave informed consent, were screened, and enrolled in the study. Two bilateral, 8mm seborrheic keratoses, one on the right and one on the left chest, were surgically removed from each subject. The wounds were photographed at all visits. Two weeks later (Visit 2), each subject was randomly assigned to apply onion extract gel to either the right or left side wound site once daily for eight weeks and no treatment on the opposite wound. The investigator was blinded to which wound was treated. At two, four, and eight weeks after gel application, right and left scars were graded by the investigator and subjects for improvement from baseline in overall appearance, texture, redness, and softness using 4-point ordinal scales (0=no improvement, 1=mild improvement; 2= moderate improvement; 3=significant improvement). Safety was evaluated by adverse events. Results: Six subjects (13.6%) experienced mild stinging that resolved spontaneously. At two weeks, the subjects rated gel-applied scars to be significantly softer than control scars (p=0.014). After four and eight weeks of application, the investigator and subjects rated all appearance variables of the gel-applied scars to be significantly more improved from baseline than control scars (p=0.017 to p<0.01). Conclusion: The new proprietary onion extract gel is safe and significantly improves scar appearance after four weeks of once-daily application.

Research paper thumbnail of Direct Evidence for Homologous Sequences on the Paracentric Regions of Human Chromosome 1

Research paper thumbnail of Assignment of Psoriasin to Human Chromosomal Band 1q21: Coordinate Overexpression of Clustered Genes is Psoriasis

Journal of Investigative Dermatology, Apr 1, 1996

Depa rtlll ents of * Derlll atolob'Y• 11R adi ation O ncology. and :j: HlIlll an Genetics. Uni ve... more Depa rtlll ents of * Derlll atolob'Y• 11R adi ation O ncology. and :j: HlIlll an Genetics. Uni versity of Mi chi gan, Ann Arbor, Mi chiga n. U.S.A. Psoriasin is an abundant low molecular weight protein in k e r a tinocy tes from psoria tic lesions. Because of simila rities ill. gene structure and expression to o ther g e nes on hUlnan chrolnosolnal band 1q21, we hypothesiz ed tha t psoriasin might also map to this region. To test this hypothesis, we identified and used a genomic A. clone (A.9.2) as a probe for fluorescent ill Sitlt hybridization. A.9. 2 detected the 1q21 region in 81 % of 52 chromosomes 1 exalnine d, although it also hybridize d t o acrocentric chromosomes. A.9. 2 DNA yielded poly m e r ase c hain reaction an~plification of a 121-bp sequ e nce colinear with psoria sin eDNA, as did T ~l C proccss of c. pithc li al di.ffc re nti ati o n. is eVO luti o.n arli y an Cie n t and well-co n se rvcd (B ere ltc r-Hahn ('(aI, 1 984). T h e re for e, th e m e hallism b y w h ic h gen es ce n tr al to th is process are regu lated is like ly to b e an cie nt and con se rv e d as we ll. O n e su c h m ech anism might in vo lve the clu sterin g of fun ction all y rc lated gen es, a rec urrent p hc n o m e n o n in eukaryotic as w e ll as pro k a ryo ti c gen o mi c organ izatio n (O hta, 1991). Ev iden cc fo r th e impo rta n ce of gc n e clustering fo r a pp ro pri ate coordin a te ge n c cx press io n is provide d by seve ral h o m eob ox ge n e cluste rs (Ge hrin g , 1 992), th e human j3-likc g lo bin gcn e c luster (To wn es and B e h rin ge r, 1 990) , and th e varia bl e regio ns of th e T-cell rece ptor 'Y ge n e (Lefran c and

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Assessment of Chin Retrusion

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of chin appeara... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of chin appearance before and after chin augmentation in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Chin Retrusion Scale. METHODS The Allergan Chin Retrusion Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 298) completed during 2 sessions occurring 3 weeks apart. RESULTS A difference of $1 point on the scale was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference, 1.07 [0.94-1.20] for clinically different image pairs and 0.51 [0.39-0.63] for not clinically different pairs). Intrarater agreement between the 2 live-subject validation sessions was substantial (mean weighted kappa = 0.79). Interrater agreement was substantial during the second rating session (0.68, primary end point). CONCLUSION The Allergan Chin Retrusion Scale is a validated and reliable scale for physician rating of severity of chin retrusion.

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Evaluation of Facial Fine Lines

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of facial fine ... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of facial fine lines before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Fine Lines Scale. METHODS The Allergan Fine Lines Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live subject validation study (N = 289) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of $1 point was shown to reflect a clinically significant difference (mean [95% CI] absolute score difference, 1.06 [0.92-1.21] for clinically different image pairs and 0.50 [0.38-0.61] for not clinically different pairs). Intrarater agreement between the 2 live subject validation sessions was almost perfect (weighted kappa = 0.85). Interrater agreement was substantial during the second rating session (0.76, primary end point). CONCLUSION The Allergan Fine Lines Scale is a validated and reliable scale for physician rating of severity of superficial fine lines.

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Evaluation of Facial Skin Texture

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of facial skin ... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of facial skin roughness before and after aesthetic treatment in practice and in clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Skin Roughness Scale. METHODS The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 290) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of $1 point was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference 1.09 [0.96-1.23] for clinically different image pairs and 0.53 [0.38-0.67] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (weighted kappa = 0.83). Interrater agreement was almost perfect during the second rating session (0.81, primary end point). CONCLUSION The Allergan Skin Roughness Scale is a validated and reliable scale for physician rating of midface skin roughness.

Research paper thumbnail of Efficacy and Safety of OnabotulinumtoxinA for Moderate-to-Severe Forehead Lines in Subjects with Upper Facial Lines

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Evaluation of Static Horizontal Forehead Lines

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of static foreh... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of static forehead lines before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Forehead Lines Scale. METHODS The Allergan Forehead Lines Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 295) completed during 2 sessions occurring 3 weeks apart. RESULTS A difference of $1 point on the scale was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.06 [0.91-1.21] for clinically different image pairs and 0.38 [0.26-0.51] for not clinically different pairs). Intrarater agreement between the 2 live-subject validation sessions was almost perfect (mean weighted kappa = 0.87). Interrater agreement was almost perfect during the second rating session (0.86, primary end point). CONCLUSION The Allergan Forehead Lines Scale is a validated and reliable scale for physician rating of static horizontal forehead lines.

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Evaluation of Volume Deficit of the Hand

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of hand appeara... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of hand appearance before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Hand Volume Deficit Scale. METHODS The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real-subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 296) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of $1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.12 [0.99-1.26] for clinically different image pairs and 0.45 [0.33-0.57] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.83). Interrater agreement was almost perfect during the second session (0.82, primary end point). CONCLUSION The Allergan Hand Volume Deficit Scale is a validated and reliable scale for physician rating of hand volume deficit.

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Evaluation of Infraorbital Hollows

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of infraorbital... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of infraorbital hollows (i.e., tear troughs) before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Infraorbital Hollows Scale. METHODS The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 297) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of $1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 0.90 [0.79-1.02] for clinically different image pairs and 0.33 [0.19-0.46] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was substantial (mean weighted kappa = 0.79). Interrater agreement was substantial during the second rating session (0.70, primary end point). CONCLUSION The Allergan Infraorbital Hollows Scale is a validated and reliable scale for physician rating severity of hollowing in the infraorbital area.

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Evaluation of Transverse Neck Lines

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of horizontal n... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of horizontal neck lines before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Transverse Neck Lines Scale. METHODS The Allergan Transverse Neck Lines Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject rating validation study (N = 297) completed during 2 sessions occurring 3 weeks apart. RESULTS A difference of $1 point on the scale was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.22 [1.09-1.35] for clinically different image pairs and 0.57 [0.42-0.72] for not clinically different pairs). Intrarater agreement between the 2 live-subject rating validation sessions was substantial (mean weighted kappa = 0.78). Interrater agreement was substantial during the second rating session (0.73, primary end point). CONCLUSION The Allergan Transverse Neck Lines Scale is a validated and reliable scale for rating of severity of neck lines.

Research paper thumbnail of <i>In Vitro</i> Antifungal Activity of Naftifine Hydrochloride against Dermatophytes

Antimicrobial Agents and Chemotherapy, Sep 1, 2013

The incidence of superficial dermatophytoses is high in developed countries, and there remains a ... more The incidence of superficial dermatophytoses is high in developed countries, and there remains a need for effective topical antifungals. In this study, we evaluated the in vitro antifungal activity of naftifine hydrochloride, the active ingredient in naftifine hydrochloride cream and gel 1% and 2%, against dermatophytes. The MICs and minimum fungicidal concentrations (MFCs) of naftifine hydrochloride against 350 clinical strains, including Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Epidermophyton floccosum, and Microsporum canis, were determined using the CLSI methodology. Subsets from this test panel were subsequently tested in a time-kill assay at 0.125؋, 0.25؋, 0.5؋, and 1؋ the MFC for each isolate. CFU counts were performed over a period of 48 h of incubation. Additionally, in order to determine the potential for resistance development, six strains were subjected to 15 serial passages in concentrations higher than the MIC for each strain. MICs were determined following each passage. The MIC range against the dermatophyte isolates tested was 0.015 to 1.0 g/ml, with naftifine hydrochloride being fungicidal against 85% of the Trichophyton species. The time-kill assay showed dose-dependent activity, with the greatest reduction in the numbers of CFU corresponding to the highest drug concentration. There was no increase in MIC for any strains following repeated exposure to naftifine hydrochloride. Naftifine hydrochloride demonstrated potent activity against all dermatophytes tested, and none of the isolates within this test panel demonstrated the potential for the development of resistance. Thus, future clinical studies of naftifine hydrochloride against dermatophytes may be warranted for the treatment of superficial dermatophytoses.

Research paper thumbnail of Development and Validation of a Photonumeric Scale for Evaluation of Volume Deficit of the Temple

Dermatologic Surgery, Oct 1, 2016

BACKGROUND A validated scale is needed for objective and reproducible comparisons of temple appea... more BACKGROUND A validated scale is needed for objective and reproducible comparisons of temple appearance before and after aesthetic treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Temple Hollowing Scale. METHODS The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 298) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of $1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.1 [0.94-1.26] for clinically different image pairs and 0.67 [0.51-0.83] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.86). Interrater agreement was almost perfect during the second session (0.81, primary endpoint). CONCLUSION The Allergan Temple Hollowing Scale is a validated and reliable scale for physician rating of temple volume deficit.

Research paper thumbnail of Safety and Effectiveness of VYC-15L, a Hyaluronic Acid Filler for Lip and Perioral Enhancement: One-Year Results From a Randomized, Controlled Study

Dermatologic Surgery, Mar 1, 2017

BACKGROUND VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel wit... more BACKGROUND VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine. OBJECTIVE To evaluate the safety and effectiveness of VYC-15L for lip and perioral enhancement versus a nonanimal stabilized HA with lidocaine (Restylane-L; NASHA). METHODS This prospective multicenter study randomized 225 adults with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) to treatment with VYC-15L or NASHA; optional touch-up was administered 30 days later. Subjects were followed for 1 year. The primary effectiveness end point was noninferiority of VYC-15L versus NASHA by mean change in LFS score from baseline to Month 3. RESULTS The primary end point was met. At Month 3, LFS responder rates were 80.3% for VYC-15L versus 70.8% for NASHA. LFS responder rates exceeded 60% through 1 year with VYC-15L. Perioral lines severity improved for 65.4% and 66.2% of VYC-15L subjects at Month 3 and Year 1, respectively. At Month 3, 96.1% and 88.2% of subjects reported improvement in FACE-Q Satisfaction With Lips and Satisfaction With Lip Lines, respectively. Severe injection site responses were reported less frequently with VYC-15L than NASHA. CONCLUSION VYC-15L was safe and effective for lip and perioral enhancement, with treatment effects lasting through 1 year.

Research paper thumbnail of An open-label pilot study of naftifine 1% gel in the treatment of seborrheic dermatitis of the scalp

An open-label pilot study of naftifine 1% gel in the treatment of seborrheic dermatitis of the scalp

PubMed, Apr 1, 2012

Topical antifungal treatment is a mainstay of therapy for Seborrehic Dermatitis (SD). Although th... more Topical antifungal treatment is a mainstay of therapy for Seborrehic Dermatitis (SD). Although the amidazole and ciclopyridine antifungals have been extensively studied, few clinical efficacy data are available for topical allylamine therapy in SD. The objective of this open-label exploratory study was to evaluate the efficacy and safety of natifine HCl 1% gel applied twice daily for 4 weeks, as topical treatment of moderate SD of the scalp. Nine subjects (5 men, 4 women) with a mean age of 56 (33-81) years with SD of the scalp were enrolled and made 4 visits to the site. At Visit 1 (Week 0), subjects were screened, enrolled, baseline efficacy data were obtained, and treatment was initiated. Subjects returned at Week 2, Week 4 (end of treatment), and Week 6 for efficacy and safety assessments. Efficacy was evaluated by changes from baseline in investigator-rated scores on 0-5-grade scales: (1) SD Global Evaluation Scale (SDGES), (2) Erythema Severity Scale, (3) Scaling Severity Scale, (4) % Scalp Involvement Scale, and subject-rated scores on the (4) Itching Severity Scale, and (5) Global Improvement Scale, where 0=none and 5=most severe. Mean severity scores for the SDGES and % Scalp Involvement scales progressively declined (improved) 66% and 54% from respective baseline levels at Week 6. Mean erythema rating decreased 38% from baseline and scaling decreased 50% from baseline by Weeks 4 and 6. Itching improved in 5 of 9 (56%) subjects by the end of treatment. A total of 8 of 9 (89%) subjects rated their symptoms as improved from baseline at the end of treatment and Week 6. There were no treatment-related adverse events during the study. These results suggest that naftifine 1% gel applied twice daily for 4 weeks is effective and safe topical treatment for moderate SD of the scalp.