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Papers by Stacy Smith

Clinical, Cosmetic and Investigational Dermatology

Journal of drugs in dermatology : JDD, 2013

Optimizing the aesthetic outcome of lip augmentation with dermal fillers, such as small gel parti... more Optimizing the aesthetic outcome of lip augmentation with dermal fillers, such as small gel particle hyaluronic acid (SGP-HA), requires skillful application of a suitable injection technique. Moreover, achieving aesthetic goals with minimal risk for adverse events requires knowledge of lip anatomy and function, clinical experience in the use of various injection techniques, and an individualized treatment approach. Clinician-patient discussion of the initial assessment of lip presentation and global appearance of lip shape and proportion is important in setting treatment expectations and establishing a basis for follow-up assessment of the effectiveness of treatment. The effectiveness and safety of SGP-HA for lip augmentation was demonstrated in a recent randomized controlled trial. This review discusses factors influencing the choice of one or a combination of techniques for injection of SGP-HA for aesthetic lip augmentation.

Journal of Cutaneous Medicine and Surgery, 2022

Background Itch and sleep disturbance due to itch are burdensome symptoms associated with atopic ... more Background Itch and sleep disturbance due to itch are burdensome symptoms associated with atopic dermatitis (AD). Rapid onset of action is important for AD treatments to improve quality of life and relieve suffering. Objectives This subanalysis evaluated how quickly baricitinib 1-mg and 2-mg reduced itch and associated sleep disturbance during the first 7 days after treatment initiation in a phase 3, double-blind, placebo-controlled trial. Methods Adult patients with AD were randomized 1:1:1 to placebo ( N = 147), baricitinib 1 mg ( N = 147) or baricitinib 2 mg ( N = 146). Patients kept daily diaries, completing the Itch Numeric Rating Scale (NRS) (itch severity from 0 = no itch to 10 = worst itch imaginable) and the Atopic Dermatitis Sleep Scale (ADSS) to measure sleep disturbance (number of nighttime awakenings because of itch). Mixed model repeated measures analysis was used to analyze change from day 1 to day 7 values. Results Patients receiving either dose of baricitinib had a ...

Journal of Drugs in Dermatology, 2021

Objective: To compare the safety and efficacy of a novel hyaluronic acid injectable gel with 0.3%... more Objective: To compare the safety and efficacy of a novel hyaluronic acid injectable gel with 0.3% lidocaine (test device) with that of a commercially available injectable hyaluronic acid gel with 0.3% lidocaine (comparator) for lip augmentation. Methods: Eligible patients (n = 158) with an overall score of very thin (n = 0) or thin (n = 1) on a 5-point Lip Fullness Grading Scale (LFGS) participated in the double-blind, randomized, multicenter study. Efficacy was assessed periodically over 6 months on a per protocol (PP) population (definitive) and a modified intent-to-treat (mITT) population (supportive). Results: In the PP population, the mean change from baseline (day 56) in LFGS score was 1.52 for the test device and 1.53 for the comparator. This 56-day change was the primary efficacy endpoint. The 95% confidence interval (CI) limits for the mean difference in scores (test device minus comparator) were-0.33 and 0.31. In the mITT population, the corresponding 95% CI limits were-0.26 and 0.31. In both populations, the lower limits,-0.33 and-0.26, were higher than the prespecified-0.50, indicating that the test device was non-inferior to comparator. The adverse event profile was similar between the treatment groups. Ninety-three percent of patients treated with test device considered themselves improved, much improved, or very much improved at day 168 compared to 82% of those treated with comparator. The corresponding investigator improvement ratings were 100% and 76%, respectively. Conclusion: For lip augmentation, the efficacy and safety of the test device is non-inferior to comparator.

Dermatologic Surgery, 2020

BACKGROUND A range of monophasic dermal fillers made of high-molecular-weight hyaluronic acid (HA... more BACKGROUND A range of monophasic dermal fillers made of high-molecular-weight hyaluronic acid (HA) chains with reduced cross-linking was developed for aesthetic procedures. OBJECTIVE The efficacy, durability, and safety of 2 of these resilient HA (RHA) fillers, and their noninferiority to an effective HA comparator available in the United States, were tested in the treatment of dynamic facial wrinkles. METHODS A 15-month, prospective, multicenter, active-controlled, randomized, double-blinded, split-face clinical trial was carried out on 174 subjects presenting moderate-to-severe bilateral nasolabial folds (NLFs). Assessed parameters included improvement on a proprietary Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale, according to Blind Live Evaluators, subjects, and treating investigators. Self-perception was evaluated with FACE-Q and satisfaction scales. RESULTS The per-protocol populations included 67 and 62 subjects of all Fitzpatrick skin-phototypes, in the 2 comparison groups. Significant improvement of mean WSRS scores and associated responder rates established the noninferiority of RHA fillers to their comparator, over 15 months. Aesthetic improvement and subject satisfaction were durably high, with no meaningful differences between the fillers. Treatments were safe and well tolerated. CONCLUSION The 2 RHA fillers are at least equivalent to a well-established comparator for the correction of NLF in subjects of diverse skin-phototypes.

Dermatologic Surgery, 2015

A polymethylmethacrylate-collagen filler is generally believed to give long-term benefits, but th... more A polymethylmethacrylate-collagen filler is generally believed to give long-term benefits, but the risk of granuloma formation over time remains unclear. To determine the incidence of granuloma formation and response to treatment and assess the degree of patient satisfaction over 5 years. Adults seeking correction of nasolabial folds underwent up to 3 injection sessions over 2 months. Subjects were then queried regularly for the development of signs and symptoms of a granuloma. Any positive responses were evaluated, and lesions suspicious for granulomas were confirmed by biopsy. Granulomas were treated at the discretion of the investigator. Subjects also completed regular satisfaction questionnaires. A total of 1,008 subjects were enrolled and 871 completed the full 5 years of the study. A biopsy-confirmed granuloma developed in 1.7% of subjects. Almost all granulomas responded to treatment. At study exit, 0.9% of subjects had an unresolved granuloma. Patient satisfaction remained high throughout the duration of the study. The incidence of granuloma formation with a polymethylmethacrylate-collagen dermal filler is low, and almost all lesions are manageable with simple therapeutic measures. Patient satisfaction remains durable over 5 years. Polymethylmethacrylate-collagen offers a well-characterized and very favorable risk/benefit profile.

Journal of drugs in dermatology : JDD

Topical drugs use a variety of ingredients to control the properties of the final product. Solid ... more Topical drugs use a variety of ingredients to control the properties of the final product. Solid phase porous microspheres (SPPM, Microsponge) have been incorporated into several topical prescription products in an effort to improve performance or tolerability. SPPMs provide a reservoir effect allowing more prolonged skin exposure to the active ingredient. They are used in products for acne vulgaris, actinic keratoses, and pigmentary changes. The differences in clinical performance between existing formulations of these common active ingredients and the formulations using SPPMs are compared and contrasted.

Plastic and reconstructive surgery, 2012

Soft-tissue augmentation with injectable fillers is commonly performed in the malar area. A four-... more Soft-tissue augmentation with injectable fillers is commonly performed in the malar area. A four-point scale, the Medicis Midface Volume Scale, was developed and validated as an objective measure of the severity of midface volume loss. Using a separate photographic guide, four investigators rated photographs (front and right and left sides, to provide a full view of the face) of 60 untreated subjects in random order during two sessions 2 or more weeks apart. Both sides of the midface were scored separately as follows: 1, fairly full; 2, mild loss of fullness; 3, moderate loss, slight hollowing; and 4, substantial loss, clearly apparent hollowing. Most subjects (mean age, 45.7 years; range, 23 to 80 years) were women (72 percent) and white (87 percent). Intraobserver agreement between sessions was "almost perfect" (weighted kappa scores) for the right (0.918; 95 percent CI, 0.887 to 0.949) and left (0.911; 95 percent CI, 0.878 to 0.943) sides. Intraobserver exact agreement ...

Journal of the American Academy of Dermatology, 2004

Background: Imiquimod has been shown to be safe and effective as a topical treatment for typical ... more Background: Imiquimod has been shown to be safe and effective as a topical treatment for typical size (Ͻ2 cm maximum diameter) superficial basal cell carcinomas (sBCCs). Objective: To evaluate the efficacy, safety and cosmetic outcome of imiquimod 5% cream for the treatment of large sBCCs. Methods: This was an open-label, multicenter phase II study conducted in Australia and New Zealand. Subjects applied imiquimod 5ϫ/week for 6 weeks to a biopsy-confirmed sBCC measuring Ն2 cm in at least one dimension. At 12 weeks posttreatment, the tumor treatment site was examined clinically for remaining sBCC followed by multiple biopsies (if clinically clear) or excisions (if clinically not clear) and examined histologically. Complete response rate was defined as the proportion of subjects at 12-weeks posttreatment with no clinical and no histological evidence of sBCC at the target tumor site. Local skin reactions (LSRs) were assessed at all study visits. Skin quality parameters were rated for the treatment site and the anatomically opposite area to judge cosmetic outcome. Results: Sixty-six subjects entered with lesions ranging between 2-48 cm 2. The complete response rate was 55/66 (83%) and 4 of 5 subjects who did not have clinical clearance of sBCC had reductions in tumor size of 13%-99%. Subgroup analysis indicated that as severity of edema, erosion and ulceration increased, so did the clearance rate. The most frequently reported adverse event was application site reaction. LSRs and application site reactions improved and resolved after cessation of treatment: only 1 subject withdrew due to LSRs. Small mean differences were seen in skin quality parameter scores between treated tumor sites and anatomically opposite areas 12 weeks posttreatment. Conclusion: Imiquimod 5% cream applied 5ϫ/week is an effective therapy for the clearance of large sBCC, having an acceptable safety profile and satisfactory cosmetic outcome. References: 1.

Journal of the American Academy of Dermatology, 2014

Background: Acne scarring remains a stubborn clinical problem. Few treatments have been shown to ... more Background: Acne scarring remains a stubborn clinical problem. Few treatments have been shown to be definitely effective for this problem. Polymethylmethacrylate (PMMA) microspheres in collagen (ArteFill, Suneva Medical Inc, Santa Barbara, CA) have shown long-term benefit for nasolabial fold treatment. A pilot study has shown benefit for PMMA-collagen in atrophic acne scarring. Objective: We sought to demonstrate the safety and effectiveness of PMMA-collagen for acne scarring in a controlled, blinded trial. Methods: Subjects with at least 4 moderate to severe rolling, atrophic scars randomly received PMMA-collagen or saline injections. Subjects underwent up to 2 injection sessions and were followed up for 6 months. Efficacy was assessed using a validated rating scale for each scar. Results: In all, 147 subjects underwent injections. Success was achieved by 64% of those treated with PMMA-collagen compared with 33% of control subjects (P = .0005). The treatment showed excellent safety with generally mild, reversible adverse events. No significant differences in efficacy or safety were noted between genders, for darker skin types, or in older age groups. Limitations: Subjects were followed up for only 6 months. Conclusion: PMMA-collagen demonstrates substantial effectiveness in the treatment of atrophic acne scars of the face while maintaining an excellent safety profile. Further follow-up should be undertaken to demonstrate longer-term benefit and safety.

Dermatologic Surgery, 2008

BACKGROUND The rapid market expansion of filler treatment options requires physicians and health ... more BACKGROUND The rapid market expansion of filler treatment options requires physicians and health care providers to fully understand differences among comparable products. OBJECTIVE The objective was to compare commercially available polymethylmethacrylate (PMMA)based soft tissue fillers to determine if there are meaningful variations in these products that could result in significantly different therapeutic profiles, especially with respect to safety. METHODS AND MATERIALS PMMA particles were evaluated for size and morphology using scanning electron microscopy (SEM) techniques. PMMA microsphere soft tissue filler products from the United States, Europe, Brazil, and Canada were compared with respect to size, homogeneity/irregularity, surface smoothness/roughness, and the presence or absence of sediment and particulate debris. RESULTS Marked differences with respect to PMMA particle morphology and related particle characteristics from a variety of products were found. Of note, some products demonstrated potentially concerning significant variability in particle size and irregular morphology. CONCLUSION It is anticipated that the variability detected in these products, based on the literature, could result in different therapeutic profiles, especially with respect to safety. Physicians and health care providers should be aware that ''comparable'' products that at a glance appear similar may not be equal.

Dermatologic Surgery, 1997

With proper technique and instrumentation, laser resurfacing for facial wrinkles has been found t... more With proper technique and instrumentation, laser resurfacing for facial wrinkles has been found to be highly effective and relatively safe. Most, if not all, of the noninfectious complications such as pigmentary changes, scarring, and persistent erythema can either be avoided or managed with appropriate therapy. Postoperative infections, on the other hand, may develop despite proper technique and instrumentation. Without proper management, they may cause significant physical morbidity and psychological distress defying the expected benefit of the procedure. To quantify the incidence and to study the characteristics of infections arising after laser resurfacing for facial wrinkles with pulsed carbon dioxide laser treatment. A retrospective study was carried out by reviewing the records of all patients undergoing laser resurfacing for facial wrinkles from January 1, 1995 to April 30, 1996. An infection is defined as a positive culture in the presence of signs or symptoms of an infection. Over 16 months, 395 procedures were performed and 17 cases of culture-proven infection recorded, an incidence of 4.3%. All patients had symptoms starting between days 2 and 10 after the operation. Over half of the patients had multiple infections with two to three microorganisms. Pseudomonas aeruginosa was the most common causative agent, found in 41% of all infected cases, followed by Staphylococcus aureus (35%), S. epidermidis (35%), and Candida species (24%). Multiple drug-resistant, gram-negative bacteria were found in four cases, implicating the possibility of hospital-acquired infections. Almost all isolates of gram-positive bacteria were resistant to both erythromycin and penicillin, but not oxacillin. With proper treatment, most patients healed normally. Only one patient had persistent, multiple atrophic scars due to locally disseminated herpes simplex infection despite proper prophylaxis and treatment. Postoperative infection is uncommon and manageable with early recognition and proper treatment. The types of infectious agents being found are very similar to those reported in burn patients. This complication has been found to be much more common in patients undergoing full face resurfacing and those using a bio-occlusive dressing postoperatively. With comprehensive preventive and management measures, it is likely that this type of uncommon, yet distressful, complication can be avoided and more successfully treated. Recommendations are made for prevention and management of suspected postoperative infections.

Dermatologic Surgery, 1999

background. The advantages of using tumescent anesthesia for ambulatory phlebectomy have recently... more background. The advantages of using tumescent anesthesia for ambulatory phlebectomy have recently been described. Previously, tumescent solutions have avoided epinephrine for concerns of toxicity given the large volume of anesthetic sometimes used. objective. To evaluate the efficacy and safety of using epinephrine in the tumescent anesthesia solution during ambulatory phlebectomy. methods. Over the course of 1 year, epinephrine in the concentration of 1:100,000 was added to the tumescent solution of patients undergoing ambulatory phlebectomy. A retrospective review of 94 sequential patients was performed to determine the rate of complications associated with the procedure. results. The complication rate was considerably improved using tumescent lidocaine with epinephrine compared to a previously performed study of tumescent lidocaine without epinephrine. The rate of hematoma was decreased to nil while the rate of hyperpigmentation decreased from 3.6% to 0%. Overall, the rate of complications was improved when epinephrine was added to the tumescent lidocaine solution. Blood pressure measured every 5 minutes and heart rate measured continuously did not significantly change before, during or after infiltration of the anesthetic solution. conclusions. Epinephrine in appropriate concentrations is clearly safe when used in the tumescent anesthetic solution during ambulatory phlebectomy and should be used to reduce the incidence of hematoma and hyperpigmentation.

Dermatologic Surgery, 2007

BACKGROUND Current soft tissue fillers are a compromise between ease of use, duration of correcti... more BACKGROUND Current soft tissue fillers are a compromise between ease of use, duration of correction, reactivity, and cost. A product utilizing calcium hydroxylapatite (CaHA) is currently being used as a soft tissue filler. OBJECTIVE The objective was to compare the efficacy and safety of CaHA microspheres versus humanbased collagen for the correction of nasolabial folds. MATERIALS AND METHODS Four centers enrolled 117 subjects with moderate to deep nasolabial folds. Subjects received CaHA on one side of the face and human collagen on the other. Up to two touch-ups were allowed. A blinded panel of experts evaluated subject photographs from initial and follow-up visits. RESULTS Seventy-nine percent of subjects had superior improvement on the CaHA side through 6 months (po.0001). For optimal correction, significantly less volume and fewer injections were needed for CaHA than for collagen (po.0001). Adverse event rates were comparable, with some increase in bruising and edema for CaHA-treated sides. Adverse event duration was similar for both groups and generally resolved within 14 to 21 days. CONCLUSION This CaHA-based product gives significantly longer-lasting correction of nasolabial folds compared to human collagen. Less total material and fewer injections are required. The adverse event profile of the product is similar to the collagen-based product. Radiesse soft tissue filler, supplies, and equipment for photographic documentation for this study were provided by BioForm Medical (San Mateo, CA). The investigators were paid an honorarium to conduct the study. Drs Busso and Bass have received compensations for presentations about Radiesse to the medical community. S oft tissue fillers are a growing category of minimally invasive therapy for the treatment of agerelated changes of the face. 1 After the introduction of bovine collagen in 1981, the search has continued for a longer-lasting, well-tolerated material. United States commercial acceptance and use has shown a significant trend toward longer-lasting dermal filler products. 2 The list of materials currently used in the United States, both approved and nonapproved, includes bovine collagen, autologous fat, hyaluronic acid (HA), polylactic acid, human collagen from recombinant technology, cadaveric human collagen, silicon, various acrylics or acrylates, and calcium hydroxylapatite (CaHA). CaHA (Radiesse, San Mateo, CA) is a mineral complex with a molecular weight of 502 Da. It is found in the human as a normal component of bones and teeth. CaHA has been used as implant or coating material in dentistry for more than 20 years. 3 Additionally, it has been used to coat prosthetic joint components to assist in fixation to normal bone. 4 During this time CaHA has proven to be an inert, reliable, well-tolerated material. 5

Archives of Dermatology, 2005

SKIN The Journal of Cutaneous Medicine, 2021

Once in circulation, sofpironium bromide rapidly hydrolyzes into its metabolite (BBI-4010), a les... more Once in circulation, sofpironium bromide rapidly hydrolyzes into its metabolite (BBI-4010), a less active anticholinergic agent, therefore reducing its potential for side effects Anticholinergic medications are useful for the management of primary axillary hyperhidrosis (AHH). However, due to inhibition of cholinergic receptors in tissues other than the targeted sweat glands, the use of both oral and topical anticholinergics for the treatment of AHH often results in systemic side effects, such as dry mouth, blurred vision, mydriasis, and urinary hesitation. Sofpironium bromide (SB) is a novel, quaternary ammonium, anticholinergic drug that is a retrometabolically designed structural analogue of glycopyrrolate. Unlike glycopyrrolate, SB includes a readily hydrolyzable ester moiety. To obtain this metabolically sensitive site, the "inactive metabolite" approach to retrometabolic drug design was used. 1 A hydrolytically sensitive function was introduced in a remote site of the molecule, away from the pharmacophore. 2 The molecular structure was further refined based on binding to the relevant muscarinic receptors, and the most potent optical isomer was selected. 3 The specific enzyme responsible for hydrolytic metabolism of SB was identified. 4 Here we review existing pharmacokinetic and pharmacodynamic data for the retrometabolically designed investigational drug SB.

Journal of Cosmetic Dermatology, 2019

Background: Injectables that behave similarly to native tissue and preserve facial expressiveness... more Background: Injectables that behave similarly to native tissue and preserve facial expressiveness represent a new frontier in aesthetic medicine. A range of fillers made of high molecular weight hyaluronic acid (HA) chains with low crosslinking have been specifically developed to complement facial dynamics. Aims: The efficacy and safety of one of these resilient HA fillers, and its noninferiority to an effective comparator available in the US, were tested in the treatment of dynamic wrinkles. Methods: A 15-month, prospective, multicenter, controlled, randomized, doubleblind, within-subject (split-face) clinical trial was conducted on 140 subjects with moderate-to-severe nasolabial folds (NLF). Study endpoints included improvement on a proprietary Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale, according to Blind Live Evaluators (BLE), subjects, and treating investigators (TI). Subject perception was evaluated with FACE-Q and satisfaction scales. Results: The per-protocol population included 88 subjects (92% women) of all Fitzpatrick phototypes, with a mean age of 57 years. WSRS improvement was significantly greater with the resilient HA than its comparator over 15 months, including at week 24 (primary endpoint), as rated by BLE and TI. Results demonstrated the noninferiority of the resilient HA filler to its comparator. Aesthetic improvement and subject satisfaction were durably high, with an overall trend toward higher scores for the resilient HA filler. Both treatments were safe and well tolerated. Conclusion: The resilient HA filler made of long chains lightly crosslinked is at least equivalent to a well-established comparator for the correction of NLF in subjects of diverse skin phototypes.

SKIN The Journal of Cutaneous Medicine, 2018

not available. Disclosure: Study sponsored by Alcaris.

Skeletal Radiology, 2008

Sarcoidosis is a systemic disease that histologically typically shows non-caseating granulomas. T... more Sarcoidosis is a systemic disease that histologically typically shows non-caseating granulomas. The most common radiologic finding is hilar and mediastinal adenopathy. Patients with widely disseminated disease may show involvement of the peripheral appendicular skeleton in 1-13% of such cases. A primary skeletal presentation without other manifestations typical of the disease is rare. We present a case of sarcoidosis in a middle-aged Caucasian man in whom the disease presented with widespread lytic lesions in the axial skeleton and long bones, mimicking metastatic disease. There was no involvement of the peripheral skeleton, skin or lungs.

Dermatologic Surgery, 2019

BACKGROUND Assessment scales are valuable tools in aesthetic clinical research and practice. OBJE... more BACKGROUND Assessment scales are valuable tools in aesthetic clinical research and practice. OBJECTIVE To validate 3 photonumeric scales covering temple volume deficit, infraorbital hollows, and chin retrusion. MATERIALS AND METHODS Subjects reflecting the whole range of the scales were assessed independently by 3 evaluators at 2 separate occasions. Intraobserver agreement (the ability of each evaluator to assess the same grade for a specific subject at both evaluation occasions) and interobserver agreement (the degree to which evaluators independently provided identical grades for the same subject) were measured by weighted kappa statistics and percent exact agreement. RESULTS Approximately 70 subjects were included in each scale validation. The predefined success criteria of an intraobserver weighted kappa coefficient of 0.6andaninterobservermedianpairwiseweightedkappacoefficientof0.6 and an interobserver median pairwise weighted kappa coefficient of 0.6andaninterobservermedianpairwiseweightedkappacoefficientof0.6 were met for each scale. These results indicate substantial agreement, both between the 2 evaluations, and between the 3 evaluators. CONCLUSION These scales covering temple volume deficit, infraorbital hollows, and chin retrusion are validated assessment tools, based on live evaluations. Intraobserver agreement (between the 2 evaluations) and interobserver agreement (between the 3 evaluators) were both substantial. The study was funded by Galderma. A. Moradi is a consultant, and clinical investigator for Galderma. Lin is employed by Galderma. S. Allen is a consultant trainer and advisor for Galderma. S. Fagien is a consultant, advisor, and clinical investigator for Galderma. M. Norberg is employed by Galderma. S. Smith is a consultant and clinical investigator for Galderma.