Challenges in Adult Acne and the Role of Skin Care in Managing the Condition.

BACKGROUND: Acne vulgaris is a complex, multifactorial, inflammatory skin condition. Although frequently presented at dermatology clinics, the literature on adult acne is scarce, particularly concerning skin barrier function and management. We aimed to provide insights into the role of skin barrier integrity in adult acne patients and the role of cleansers and moisturizers as adjunctive to treating and maintaining adult acne.   Methods: A panel of eight dermatologists who treat adult patients with acne developed a consensus paper on the role of skin barrier function and skin care in adult acne management. The modified Delphi method comprised a face-to-face meeting and online follow-up to discuss the results of a scoping literature review. Drawing from their experience and opinions, they agreed on seven consensus statements.   Results: Epidermal barrier dysfunction plays a vital role in acne pathogenesis and asymmetrically impacts adult female acne. Erythema, pruritus, peeling, and xerosis are common adverse effects of first-line acne treatment options and, if not appropriately counseled and managed, can exacerbate, leading to regimen nonadherence and poor patient experience and outcomes. CONCLUSION: Improving patient knowledge of comprehensive acne treatments, including quality adjunctive cleansers and moisturizers, may maximize regimen efficacy and provide patients with personalized and successful acne treatment and maintenance tools. J Drugs Dermatol. 2024;23(8):674-679.     doi:10.36849/JDD.8471.

A Prospective, Multi-Center Study to Evaluate the Safety and Efficacy of a Vegan Nutraceutical to Improve Hair Growth and Quality in Females Following a Plant-Based Diet

Hair thinning affects upwards of 50% of women by age 50, impacting their social-emotional wellbeing. It is a condition now thought to be driven by a multi-factorial etiology, including diet and nutrition. Women following vegan, vegetarian, or other plant-based diets have specific needs for nutrients traditionally sourced from animals, which could affect hair health. To support hair growth and quality in women following a plant-based diet, a novel vegan nutraceutical (Nutrafol Women's Vegan Capsules, Nutraceutical Wellness, Inc., New York, NY) was evaluated for its ability to support hair health. The objectives of this 6-month, multi-site, single-blind prospective clinical study was to evaluate the safety and efficacy of the nutraceutical to improve hair growth and quality in women consuming a plant-based diet. The primary endpoint in this study was an increase in terminal hair count at day 180 compared with baseline, as assessed through phototrichogram analysis. Ninety-five subjects completed the study. Daily intake of the nutraceutical resulted in a significant increase in the number of terminal hairs at day 90 (P<0.01) and day 180 (P<0.01). There was also an increase in total hair counts (P<0.01), the terminal-to-vellus ratio (P<0.01), and a decrease in shedding (P<0.01). Global Investigator Ratings revealed improved hair growth (P<0.00001) and overall quality (P<0.00001). In-person hair strength and brittleness assessments significantly improved as well (P<0.01 for both). A significant proportion of subjects reported improved hair quality, appearance, texture, and volume. Hair problems affecting the quality of life of the subjects were also reported as improved. This study demonstrated significant improvements in hair growth and quality in a plant-based population with a vegan nutraceutical. ClinicalTrials.gov Identifier: NCT05332743. J Drugs Dermatol. 2024;23(8):661-668.  doi:10.36849/JDD.8421.

A Seven-week, Open-label Trial Evaluating the Safety and Efficacy of a Photopneumatic Device for Mitigating Mild-to-Moderate Acne in Healthy Adolescents and Young Adults.

Objective: Photopneumatic devices combine gentle vacuum with pulsed broadband light to treat acne. This seven-week, open-label, single-group study evaluated the efficacy and safety of a photopneumatic device as acne monotherapy. Methods: Male and female subjects between the ages of 12 and 40 years with any Fitzpatrick Skin Phototype were enrolled (N=30). Subjects had facial acne and a baseline Investigator's Global Assessment (IGA) score of 2 (mild) or 3 (moderate), with ≥10 to ≤50 inflammatory lesions, ≥10 but ≤100 non-inflammatory lesions, and ≤1 facial nodule. The primary efficacy endpoints were change in baseline lesion counts and the percentage of subjects achieving a ≥1-grade reduction IGA Score at Day 49. Secondary efficacy endpoints included changes in Acne Quality of Life, self-assessment, and satisfaction scores. Adverse events and tolerability were assessed. Results: Inflammatory and non-inflammatory lesion counts significantly decreased at all time points versus baseline (for each, p<0.001); IGA scores were improved from baseline at most timepoints and 66.7 percent (20/30) achieved ≥1-grade IGA reduction at Day 49 (p<0.001). Consistent improvements in Acne Self-assessment, Acne-specific Quality of Life, and Treatment Satisfaction Questionnaires were reported. All subjects had favorable investigator and subject tolerability assessments. Limitations: This study was limited by its small sample size and open-label study design. Conclusion: Photopneumatic monotherapy significantly reduced acne lesions and resulted in clearer skin in all Fitzpatrick skin types. Adverse events were minor and subject satisfaction was favorable. Customizable energy and vacuum device settings makes the photopneumatic therapy device unique, allowing for a tailored individual approach to treating mild-to-moderate acne. Clinical Trial Idenifier Number: NCT06043102 (clinicaltrials.gov).

Trifarotene Reduces Risk for Atrophic Acne Scars: Results from A Phase 4 Controlled Study.

BACKGROUND: Atrophic acne scarring often accompanies acne vulgaris. The efficacy of topical retinoids for treatment of acne is well documented; however, evidence for use in atrophic acne scars is limited. METHODS: In this randomized, split-face, double-blind study, subjects (age: 17-34 years, N = 121) with moderate-to-severe facial acne, with acne scars present, were treated with either trifarotene 50 µg/g or vehicle once daily for 24 weeks. Efficacy was assessed by absolute and percent change from baseline in atrophic acne scar counts, Scar Global assessment (SGA), and IGA success rates as well as acne lesion counts. RESULTS: At week 24, a statistically significantly greater reduction in the mean absolute change from baseline in the total atrophic scar count was noted in the trifarotene- vs vehicle-treated area (- 5.9 vs - 2.7; p < 0.0001) with differences between sides noted as early as week 2 (- 1.5 vs - 0.7; p = 0.0072). The SGA success rate was higher in the trifarotene side at week 12 (14.9% vs 5.0%, P < 0.05) and improved through week 24 (31.3% vs 8.1%, P < 0.001). Similarly, at week 24, the IGA success rate was higher with trifarotene (63.6% vs 31.3%, P < 0.0001) along with reductions in total (70% vs 45%) and inflammatory (76% vs 48%) lesion counts. The incidence of treatment-emergent adverse events was 5.8% (trifarotene) and 2.5% (vehicle); most common (> 1%) was skin tightness (1.7% vs 0.8%), and all events were mild to moderate in severity. CONCLUSIONS: Trifarotene was effective and well tolerated in treating moderate-to-severe facial acne and reducing atrophic acne scars, with reduction of total atrophic scar count as early as week 2. TRIAL REGISTRATION: Clinicaltrials.gov NCT04856904.

Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction.

BACKGROUND: Tapencarium (RZL-012) (5-(3.6-dibromo-9H-carbazol-9-yl)-N, N, N-trimethylpentan-1-aminium chloride) is a novel injectable synthetic molecule with cytolytic properties, capable of reducing subcutaneous fat volume. OBJECTIVES: The goal of this 3-armed, randomized, double-blind, placebo-controlled phase 2b study was to determine the safety and efficacy of low- and high-dose RZL-012 vs placebo on submental fat (SMF) reduction. METHODS: Patients (n = 151, age 18-65 years) with excess SMF received a single treatment session of RZL-012 or placebo in the submental area, after which they were monitored for 84 days. SMF was assessed at baseline and after dosing with newly developed scales, namely the Clinician Chin Assessment Tool (C-CAT) and Subject Chin Assessment Tool (S-CAT). SMF was also assessed by magnetic resonance imaging (MRI) at screening and on Day 84 after treatment. RESULTS: The proportion of patients who had a 1-grade or 2-grade improvement in C-CAT and/or S-CAT on Day 84 vs baseline was significantly higher in the high-dose RZL-012 group vs the placebo group (P < .002). The relative percentage reduction in MRI-measured SMF volume (Day 84 vs screening) was significantly greater in the high-dose RZL-012 group vs the low-dose RZL-012 or the placebo group (P < .0001). Local injection site reactions were the most common adverse events (AEs). CONCLUSIONS: A single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, patients, and MRI. From a safety perspective, there were no serious AEs and no clinically significant changes in vital signs or laboratory tests over the course of the study.

Efficacy and Safety of DaxibotulinumtoxinA for Injection in the Treatment of Glabellar Lines by Age and Race: Subgroup Analysis of the SAKURA Clinical Trials.

BACKGROUND: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation approved for the treatment of glabellar lines. The efficacy, safety, and extended duration of response of DAXI 40 U for glabellar lines were demonstrated in 2 Phase 3, randomized, double-blind studies (SAKURA 1 and 2) and a Phase 3 open-label trial (SAKURA 3). OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of the first DAXI 40 U treatment received in SAKURA 1, 2, or 3 across age and race subgroups. METHODS: Adults with moderate-to-severe glabellar lines (Investigator Global Assessment-Frown Wrinkle Severity [IGA-FWS] and Patient FWS [PFWS] scales) were evaluated for glabellar line severity for ≤36 weeks after the first DAXI treatment. Efficacy and safety were analyzed by age (18-45, >45-55, and >55 years) and race (Asian, Black and African American, and White). RESULTS: Overall, 2785 patients were included in the efficacy analysis. The proportion of patients achieving none or mild glabellar line severity at maximum frown (IGA-FWS) after DAXI treatment was high in all age and race subgroups (>96% at Week 4). Glabellar line severity of none or mild by composite IGA-FWS and PFWS rating was maintained for a median of 24.0 weeks in all age subgroups, and for 27.0, 25.3, and 24.0 weeks in the Asian, Black and African American, and White subgroups, respectively. Treatment-emergent adverse events were similar across all subgroups. CONCLUSIONS: Consistent with the overall study population, DAXI 40 U demonstrated a high response rate and duration of effect of ≥24 weeks across all age and race subgroups.

The Future of Contract Research Organizations in Dermatology and Aesthetic Research.

Objective: Dermatology and aesthetic medicine has experienced significant growth in recent years, driven by industry-sponsored research performed by clinical investigators. Contract research organizations (CROs) play an important role to ensure clinical trials are run efficiently, ethically, and according to Good Clinical Practice. An advisory group of dermatologists and aesthetic researchers was assembled to obtain feedback about CRO experiences for developing a "next-generation" specialty CRO for dermatology and aesthetic medicine. Methods: Experienced dermatologists and aesthetic physician researchers convened during the 2022 Winter Dermatology Annual Meeting in Kauai, Hawaii, to discuss experiences and make suggestions regarding CROs. Topics included positive and negative aspects of CRO experiences, desirable CRO services, and how CROs can be improved. Results: Benefits of working with CROs include project, data, and resource management and availability of technology. Desired functions include rapid study start-up, subject recruitment, and accurate and organized site-related documentation. Other qualities include access to large subject populations close to study locations, use of CRO-based clinical research assistants to support principal investigators across study sites, and scientific consultation, protocol development, medical writing, project management, clinical and medical monitoring, data management, biostatistics, and pharmacovigilance. Conclusion: CROs serve a vital role in the development process of drug, device, and therapeutics; however, it is important that changes to traditional CRO models are made to provide improved interactions with researchers in dermatology and aesthetic medicine.

A Randomized Trial to Assess Effectiveness and Safety of a Hyaluronic Acid Filler for Chin Augmentation and Correction of Chin Retrusion.

BACKGROUND: The chin is important for facial appearance, affecting overall balance and harmony of the face. The purpose of this study was to evaluate effectiveness of the hyaluronic acid filler Restylane Defyne for chin augmentation and correction of chin retrusion versus a no-treatment control. METHODS: Male and female subjects, aged 22 years or older, with mild to moderate chin retrusion, were randomized 3:1 to the hyaluronic acid filler Restylane Defyne ( n = 107) or no treatment ( n = 33). Assessments included live, blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale), aesthetic improvement (Global Aesthetic Improvement Scale), subject-reported FACE-Q Satisfaction with Chin, and safety follow-up. RESULTS: Galderma Chin Retrusion Scale responder rate (≥1 grade improvement) was higher for the hyaluronic acid filler Restylane Defyne (81 percent) than for control (6 percent) ( p < 0.001) at week 12, and remained higher at week 48 (74 percent versus 11 percent; p < 0.001). Aesthetic improvement rates were high throughout the study as reported by investigators (≥96 percent) and subjects (≥85 percent). Subject satisfaction was higher in the hyaluronic acid filler Restylane Defyne group than in the control group at week 12 ( p < 0.001). In the individual FACE-Q scale items, 87 to 98 percent of subjects were satisfied at week 12. Treatment-related adverse events were mild to moderate. CONCLUSIONS: The hyaluronic acid filler Restylane Defyne was safe and effective for augmentation of the chin region to improve the chin profile and associated with high aesthetic improvement and subject satisfaction. Effectiveness was sustained throughout 48 weeks. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

A Long-Term Study of the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women.

The prevalence of female hair loss and hair thinning increases with advancing age and is most common among post-menopausal women. Recent statistics show that by age 60, an estimated 80% of women experience hair loss. A previous publication detailing the results of the 6-month randomized, double-blind, placebo-controlled phase of this study demonstrated the ability of a nutraceutical supplement to significantly improve hair growth and shedding compared to placebo. Here, we present results from a subsequent 6-month, open-label extension phase assessing the continued safety and efficacy of this nutraceutical for promoting and improving hair growth and evaluate potential long-term benefits on quality of life and menopausal symptoms. After a total of 12 months with the active nutraceutical, subjects had progressive improvements in hair growth, quality, and shedding. Quality of life measures and menopausal symptoms also improved over the duration of the study. When transitioned to daily intake of the supplement, subjects previously treated with placebo achieved significant increases in all hair counts, a significant decrease in shedding, and significant improvement in blinded investigator global hair growth and quality assessments. The results of this long-term study demonstrate that continued use of a novel nutraceutical provides significant incremental improvement over the beneficial effects achieved during the initial 6-month randomized, placebo-controlled phase. Continued use may provide ongoing improvements in hair growth and exert a positive effect on secondary symptoms of menopause, and quality of life in perimenopausal, menopausal, and postmenopausal women with selfperceived thinning hair (ClinicalTrials.gov Identifier: NCT04048031). J Drugs Dermatol. 2022;21(7):776-783. doi:10.36849/JDD.6912.

Subject satisfaction and psychological well-being with escalating abobotulinumtoxinA injection dose for the treatment of moderate to severe glabellar lines.

BACKGROUND: Previous studies indicate that the efficacy and durability of a single AbobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines may be enhanced with increasing dose, while safety outcomes remain consistent with those of the licensed dose (50 U). AIMS: Evaluation of subject-reported indicators of treatment efficacy, satisfaction, and psychological well-being with ABO dose escalation. METHODS: A Phase 2, 36-week, multicenter, randomized, dose-ranging, double-blind, placebo-controlled study was conducted in adults with moderate to severe glabellar lines. Subjects received a single ABO treatment, dosed at 50, 75, 100, or 125 U, or placebo. Efficacy endpoints comprised subject-assessed improvement in line severity of ≥1-grade from baseline at maximum frown, global aesthetic improvement scale (GAIS) grade, FACE-Q™ appraisal of lines, psychological well-being and age, and subject satisfaction. RESULTS: The study included 399 subjects (88.2% were female). Respective responder rates (≥1-grade improvement) with ABO 50-125 U doses ranged between 96.3%-100% at Week 4, 65.0%-67.9% at Week 24, and 33.8%-44.4% at Week 36. GAIS responder rate and FACE-Q appraisal of lines showed a similar pattern of change. Satisfaction was high and psychological well-being was improved from Week 4 through Week 36, with natural, youthful, and refreshed appearance reported for all ABO doses. CONCLUSIONS: A single ABO treatment (dosed at 50-125 U) provided significant and sustained improvements in glabellar line severity over durations up to 36 weeks, versus placebo. Treatment satisfaction was high with all doses. Participants reported natural and youthful appearance, alongside improvements in psychological well-being.

The Future of Contract Research Organizations in Dermatology and Aesthetic Research.

Objective: Dermatology and aesthetic medicine has experienced significant growth in recent years, driven by industry-sponsored research performed by clinical investigators. Contract research organizations (CROs) play an important role to ensure clinical trials are run efficiently, ethically, and according to Good Clinical Practice. An advisory group of dermatologists and aesthetic researchers was assembled to obtain feedback about CRO experiences for developing a "next-generation" specialty CRO for dermatology and aesthetic medicine. Methods: Experienced dermatologists and aesthetic physician researchers convened during the 2022 Winter Dermatology Annual Meeting in Kauai, Hawaii, to discuss experiences and make suggestions regarding CROs. Topics included positive and negative aspects of CRO experiences, desirable CRO services, and how CROs can be improved. Results: Benefits of working with CROs include project, data, and resource management and availability of technology. Desired functions include rapid study start-up, subject recruitment, and accurate and organized site-related documentation. Other qualities include access to large subject populations close to study locations, use of CRO-based clinical research assistants to support principal investigators across study sites, and scientific consultation, protocol development, medical writing, project management, clinical and medical monitoring, data management, biostatistics, and pharmacovigilance. Conclusion: CROs serve a vital role in the development process of drug, device, and therapeutics; however, it is important that changes to traditional CRO models are made to provide improved interactions with researchers in dermatology and aesthetic medicine.

Treatment options for androgenetic alopecia: Efficacy, side effects, compliance, financial considerations, and ethics.

BACKGROUND: Androgenetic alopecia (AGA) is the most common form of hair loss consisting of a characteristic receding frontal hairline in men and diffuse hair thinning in women, with frontal hairline retention, and can impact an individual's quality of life. The condition is primarily mediated by 5-alpha-reductase and dihydrotestosterone (DHT) which causes hair follicles to undergo miniaturization and shortening of successive anagen cycles. Although a variety of medical, surgical, light-based and nutraceutical treatment options are available to slow or reverse the progression of AGA, it can be challenging to select appropriate therapies for this chronic condition. AIMS: To highlight treatment options for androgenetic alopecia taking into consideration the efficacy, side effect profiles, practicality of treatment (compliance), and costs to help clinicians offer ethically appropriate treatment regimens to their patients. MATERIALS AND METHODS: A literature search was conducted using electronic databases (Medline, PubMed, Embase, CINAHL, EBSCO) and textbooks, in addition to the authors' and other practitioners' clinical experiences in treating androgenetic alopecia, and the findings are presented here. RESULTS: Although topical minoxidil, oral finasteride, and low-level light therapy are the only FDA-approved therapies to treat AGA, they are just a fraction of the treatment options available, including other oral and topical modalities, hormonal therapies, nutraceuticals, PRP and exosome treatments, and hair transplantation. DISCUSSION: Androgenetic alopecia therapy remains challenging as treatment selection involves ethical, evidence-based decision-making and consideration of each individual patient's needs, compliance, budget, extent of hair loss, and aesthetic goals, independent of potential financial benefits to the practitioners.

AbobotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines: A Randomized, Dose-Escalating, Double-Blind Study.

OBJECTIVE: To evaluate the efficacy and safety of AbobotulinumtoxinA (ABO) dose escalation in the correction of moderate-to-severe glabellar lines. DESIGN: Phase 2, 36-week, multicenter, randomized, dose-ranging, double-blind, placebo-controlled study. METHODS: Adults with moderate-to-severe glabellar lines received a single ABO treatment, dosed at 50, 75, 100, or 125 U, or placebo. Primary endpoint was week 4 composite ≥2-grade responder rate among those achieving a severity score of 0 (none) or 1 (mild) at maximum frown, evaluated using concurrent investigator and subject assessments. Secondary endpoints included ≥1-grade severity improvement, duration of effect, and reporting of treatment-emergent adverse events (TEAEs). RESULTS: Overall, 399 subjects were included (88.2% were female). Week 4 composite ≥2-grade ABO responder rate was 80.0% (50 U), 88.8% (75 U), 90.0% (100 U) and 95.1% (125 U), versus 2.6% with placebo (P<0.001). Responder rate (≥1-grade) ranged between 53% (50 U) and 69% (125 U) at week 24 and between 18% (50 U) and 31% (125 U) at week 36. Median time (weeks) to return to baseline severity/worse, among those scoring 0 (none) or 1 (mild), was 32.3 (50 U), 34.3 (75 U), 36.0 (100 U) and 36.6 (125 U), versus 23.7 (placebo). ABO-related TEAEs were reported in 4% of subjects (80% were mild). No seroconversion to ABO neutralizing antibodies was seen. CONCLUSION: A single ABO treatment provided rapid and effective improvements in glabellar line severity at all doses. Higher doses tended to demonstrate elevated response rates and longer duration of effect. All ABO doses were well-tolerated with low TEAE incidence. J Drugs Dermatol. 2021;20(9):980-987. doi:10.36849/JDD.6263.

A Randomized, Double-blind, Placebo-controlled Clinical Study Investigating the Efficacy and Tolerability of a Peptide Serum Targeting Expression Lines.

Clinical Trial ID: NCT0454597 BACKGROUND: Mimetic wrinkles, commonly referred to as expression lines, form perpendicular to anatomical regions subjected to repeated facial muscle contraction. Neuromodulating peptides have biological activity and can offer a solution to those concerned with expression lines and facial aging. OBJECTIVE: The objective of this randomized, double-blind, placebo-controlled study was to assess the efficacy and tolerability of a line-targeting peptide serum (LTPS) as a stand-alone treatment in improving expression lines and skin health. METHODS: This was an institutional review board-approved study involving healthy subjects. Fifty-five female subjects, 35 to 60 years old, Fitzpatrick Skin Type I to VI, with mild to moderate global face fine lines and wrinkles were recruited. Subjects were randomized to apply LTPS or a placebo serum to their face twice daily for twelve weeks. Short-term efficacy was assessed after fifteen minutes of serum application at baseline. Long-term efficacy and tolerability, self-assessment questionnaire, and VISIA® clinical photography were performed at baseline, Weeks 4, 8, and 12. 3D PRIMOS CR imaging and wrinkle analysis were obtained at baseline and Weeks 8 and 12. RESULTS: The LTPS significantly improved expression lines at fifteen minutes (short term), Weeks 4, 8, and 12 (long term) when compared to the placebo serum as evaluated by a board-certified dermatologist. The LTPS significantly outperformed the placebo serum in improving skin parameters at all time points. VISIA and PRIMOS CR wrinkle analysis substantiated the LTPS's efficacy. LTPS was well-perceived and well tolerated by the subjects. CONCLUSION: This IRB-approved clinical study demonstrated that LTPS was effective in improving expression lines, wrinkles, and skin health after twelve weeks of application.

Nutraceuticals.

Hair loss has a multifactorial etiology that includes internal and external triggers. These include poor diet and nutrition (extrinsic), as well as the natural aging process (intrinsic). Other external factors include pollution, hair products, hair styling, and ultraviolet exposure, which can cause free radical formation, oxidative stress, and microinflammation at the site of the hair follicles. Botanic substances have demonstrated antioxidant, anti-inflammatory, and immune-enhancing properties. Vitamins and minerals are needed when deficiencies are apparent or demonstrate efficacy at higher doses than normally found in one's diet. The safety and efficacy of oral nutraceuticals have been demonstrated in clinical trials.

Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis.

BACKGROUND: The tubulin polymerization and Src kinase signaling inhibitor tirbanibulin is being investigated as a topical treatment for actinic keratosis, a precursor of squamous-cell carcinoma. METHODS: In two identically designed double-blind trials, we randomly assigned, in a 1:1 ratio, adults with actinic keratoses on the face or scalp to receive either topical tirbanibulin or vehicle (placebo) ointment. The ointment was applied by the patients to a 25-cm2 contiguous area containing four to eight lesions once daily for 5 consecutive days. The primary outcome was the percentage of patients with a complete (100%) reduction in the number of lesions in the application area at day 57. The secondary outcome was the percentage of patients with a partial (≥75%) reduction in the number of lesions within the application area at day 57. The incidence of recurrence was evaluated at 1 year. Local reactions were scored with the use of 4-point scale (ranging from 0 [absent] to 3 [severe]). RESULTS: A total of 702 patients were enrolled in the two trials (351 patients per trial). Complete clearance in trial 1 occurred in 44% of the patients (77 of 175) in the tirbanibulin group and in 5% of those (8 of 176) in the vehicle group (difference, 40 percentage points; 95% confidence interval [CI], 32 to 47; P<0.001); in trial 2, the percentages were 54% (97 of 178 patients) and 13% (22 of 173), respectively (difference, 42 percentage points; 95% CI, 33 to 51; P<0.001). The percentages of patients with partial clearance were significantly higher in the tirbanibulin groups than in the vehicle groups. At 1 year, the estimated percentage of patients with recurrent lesions was 47% among patients who had had a complete response to tirbanibulin. The most common local reactions to tirbanibulin were erythema in 91% of the patients and flaking or scaling in 82%. Adverse events with tirbanibulin were application-site pain in 10% of the patients and pruritus in 9%, all of which resolved. CONCLUSIONS: In two identically designed trials, tirbanibulin 1% ointment applied once daily for 5 days was superior to vehicle for the treatment of actinic keratosis at 2 months but was associated with transient local reactions and recurrence of lesions at 1 year. Trials comparing tirbanibulin with conventional treatments and that have longer follow-up are needed to determine the effects of tirbanibulin therapy on actinic keratosis. (Funded by Athenex; ClinicalTrials.gov numbers, NCT03285477 and NCT03285490.).

A Randomized, Double-Blind, Placebo-Controlled Study of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women With Thinning Hair.

Hair loss is a complex and multi-factorial problem that is associated with significant psychological morbidity in women. Menopausal women represent a significant percentage of those affected, since the menopausal hormonal transition can be a contributing factor. A novel nutraceutical supplement has been specifically formulated with phytoactives to improve hair growth and quality in menopausal women (Nutrafol® Women’s Balance Capsules). The objective of this 6-month, randomized, double-blind, placebo-controlled study was to assess the safety and efficacy of this oral supplement to promote hair growth in perimenopausal, menopausal, and postmenopausal women with self-perceived thinning. Subjects were randomized to the study supplement (n=40) or placebo (n=30). The primary endpoint was a statistically significant increase in the number of terminal and vellus hairs based on phototrichogram analysis. Daily intake of the nutraceutical supplement resulted in progressive and significant increase in terminal and total hair counts on days 90 (P<0.01) and 180 (P<0.01) compared to placebo. The vellus hair counts significantly increased for the active treatment group (P<0.05) by day 180 while significantly decreasing for the placebo group subjects. Hair shedding progressively and significantly decreased for the active group compared to placebo, culminating in a reduction of 32.41% by day 180 (P<0.01). The study supplement was well-tolerated. ClinicalTrials.gov Identifier: NCT04048031 J Drugs Dermatol. 2021;20(1):55-61. doi:10.36849/JDD.5701 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study.

BACKGROUND: SAKURA 3 was a Phase 3, open-label, repeat-dose safety study of DaxibotulinumtoxinA for Injection (DAXI); a component of the largest Phase 3 clinical development program of an aesthetic neuromodulator in glabellar lines. OBJECTIVE: To evaluate the use of DAXI (40U) up to 3 treatments for moderate or severe glabellar lines. METHODS: Eligible subjects rolled over from the placebo-controlled trials (n = 477) or were de novo (n = 2,214) and received 1 to 3 treatments over a maximum of 84 weeks. Safety and efficacy were evaluated at least every 4 weeks up to Week 36 (Treatments 1 and 2) and Week 12 (Treatment 3). Select subjects could be retreated after Week 12 if glabellar lines returned to baseline. RESULTS: Safety results are reported for 2,691 subjects, of which 882 received a second treatment and 568 a third. Treatment-related adverse events (AEs) occurred in 17.8% of subjects, which were generally mild and resolved. No serious AEs were treatment-related. Eyelid ptosis occurred in 0.9% of treatments. Adverse events were consistent across treatments and no new safety signals were observed. CONCLUSION: The safety of DAXI in this large open-label safety study confirms the findings from the pivotal Phase 3 trials, providing reassurance in its overall safety profile.

Safety and Effectiveness of an Automated Microneedling Device in Improving Acne Scarring.

OBJECTIVE: To assess the effectiveness of the amiea med (amiea med, MT.DERM GmbH, Berlin, Germany) automated microneedling device in reducing facial atrophic acne scars. STUDY DESIGN: Open label, single center. PARTICIPANTS: Healthy males and females, aged 18 to 65 years, with signs of facial atrophic acne scarring were selected. After consenting and satisfying inclusion criteria, each subject underwent four microneedling sessions 30 days apart. Subjects were assessed at baseline and three months after the last treatment. MEASUREMENTS: Acne scars were classified according to Jacob classification. Physician assessment of acne scarring severity was carried out using the Goodman and Baron grading scale. Subjects graded their redness, pain and discomfort on the evening of the treatment and up to seven days posttreatment using a subject diary. RESULTS: Three months after the last treatment, facial acne scars had improved by 0.91 of a grade [CI. 0.78-1.05] according to Goodman and Baron Grading Scale (p<0.001). Improvement in acne scarring was not restricted to severity of grade,with no difference seen in Fitzpatrick skin types. According to Jacob classification, rolling scars showed the greatest improvement, with a mean improvement of 1.06 of a grade at the final assessment (p<0.001). CONCLUSION: This study demonstrates that four microneedling treatments of facial skin, spaced four weeks apart, significantly improves the appearance of facial acne scarring. The treatment is well tolerated with minimal pain, discomfort, and downtime. Side effects appear minor and easily managed compared to other more aggressive technologies. STUDY REGISTRATION: German Register for Clinical studies (DRKS) No [DRKS00013187].