Efficacy of ceramides and niacinamide-containing moisturizer versus hydrophilic cream in combination with topical anti-acne treatment in mild to moderate acne vulgaris: A split face, double-blinded, randomized controlled trial.

INTRODUCTION: Topical therapy is the mainstay treatment of acne, and topical retinoids such as tretinoin, tazarotene, and adapalene are recommended as the first-line therapy for mild to moderate acne. However, the cutaneous irritations may occur, and the dermocosmetics are recommended to prevent side effects of anti-acne drugs and adhere to treatment. Thus, this study aims to compare the efficacy and tolerability of ceramides and niacinamide-containing moisturizer (CCM) versus hydrophilic cream in combination with topical anti-acne treatment in mild to moderate acne vulgaris. METHODS: This was an 8-week, randomized, double-blinded, split face study in 40 patients assigned for topical anti-acne medications (5% benzoyl peroxide and 0.1% adapalene gel), then randomly applied CCM or hydrophilic cream. All patients were followed at week 0, 2, 4, and 8 for acne improvement, adverse reactions, biometric, and biophysical evaluation. RESULTS: CCM could significantly improve the non-inflammatory, inflammatory, and total acne lesions compared with hydrophilic cream after week 8 of treatment. Interestingly, there was an improvement of global worst score, hemoglobin index, melanin index, TEWL, skin hydration, sebum production, and skin surface pH, with no statistically significant differences between the two treatments. No serious side effects from clinical application of CCM and hydrophilic cream in mild to moderate acne vulgaris patients. CONCLUSION: Ceramide and niacinamide-containing moisturizer in combination with anti-acne medication can significantly improve acne lesions and decrease cutaneous irritations toward a satisfactory treatment outcome of mild to moderate acne vulgaris.

Comparison of the effect of topical triamcinolone 0.1% cream with sulfur 2.0% cream in the treatment of patients with hand eczema: A randomized controlled trial.

BACKGROUND: Hand eczema (HE) is a common and heterogeneous condition. It has a wide range of etiologies and clinical manifestations. In this study the efficacy of triamcinolone 0.1% cream and sulfur 2% creams was compared in treating patients with HE. METHODS: This randomized, triple-blind clinical trial was performed on 70 patients with HE (including 70 right and 70 left hands). In this study, two creams were used including triamcinolone 0.1% and sulfur 2.0%. Patients were treated with these creams twice a day (once in every 12 h) for 4 weeks. Follow-up was 4 weeks after treatment. Hand Eczema Severity Index (HECSI), itching, dryness, burning sensation, and erythema scores were collected three times during the study and compared between treatment regimens. RESULTS: Findings showed that both triamcinolone (0.1%) and sulfur (2.0%) creams could significantly reduce the scores of HECSI, itching, dryness, burning sensation, and erythema, and the therapeutic effects lasted for at least 4 weeks after cessation of topical treatment. CONCLUSION: Topical sulfur cream (2.0%) is as effective as triamcinolone (0.1%) cream in treatment of HE without any prominent adverse reactions.

Combination of 5% cysteamine and 4% nicotinamide in melasma: Efficacy, tolerability, and safety.

BACKGROUND: Melasma is a chronic dermatosis that impacts the patient's quality of life and can present considerable challenges in terms of effective treatment. OBJECTIVE: To evaluate the effectiveness, tolerability, and safety of 5% cysteamine combined with 4% nicotinamide in female subjects with melasma. METHODS: This single-center, single-arm, prospective, open-label study evaluated patients with melasma using a combination cream of 5% cysteamine and 4% nicotinamide in a progressive regimen (60 min in the first month, 120 min in the second month, and 180 min in the third month). RESULTS: Overall, 35 treated subjects exhibited reduced modified Melasma Area and Severity Index (mMASI) (p < 0.001) and decreased MelasQoL scores (p < 0.001), accompanied by improved brightness, luminosity, homogeneity, and spot intensity (p < 0.001). Photographic and colorimetric analysis revealed smaller spots and improved homogeneity. LIMITATIONS: Adherence to progressive daily treatment could not be evaluated long-term. CONCLUSION: A combination cream comprising 5% cysteamine and 4% nicotinamide was effective, tolerable, and safe for treating melasma.

Unraveling the mirage of fairness cream commercials: A cross-sectional analysis of commercials from South Asia.

BACKGROUND: Fairness products are an essential component of daily beauty routines for many individuals in subcontinental Asia. However, it is important to be aware that these products often contain ingredients that can be detrimental to the skin and are banned in several developed countries. OBJECTIVE: Our study aims to analyze the content of fairness cream commercials in order to gain a deeper understanding of the information used to persuade and influence consumers to use these products. METHODS: Fairness cream commercials originating from countries in subcontinental Asia, including India, Pakistan, Bangladesh, Sri Lanka, and Nepal, were specifically searched and analyzed on the YouTube platform. RESULTS: An analysis of 152 fairness cream commercials on YouTube identified 84.21% of commercials targeted female consumers, while only 15.79% targeted male consumers. 77.63% of commercials used celebrities in their commercials and 47.37% of commercials mentioned specific ingredients. CONCLUSIONS: Based on our findings, it is crucial for dermatologists to take an active role in educating patients and consumers about the potential risks associated with certain ingredients found in fairness creams. Dermatologists should emphasize the importance of prioritizing overall skin health rather than solely focusing on skin lightening.

Long-Term Safety and Efficacy of Twice-Daily Topical Clascoterone Cream 1% in Patients Greater Than or Equal to 12 Years of Age With Acne Vulgaris.

BACKGROUND: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged ≥ 12 years based on results from two 12-week Phase 3 studies in patients with moderate-to-severe acne. Safety and efficacy of clascoterone in patients aged ≥ 12 years from an open-label, long-term extension study are presented.  Methods: Enrolled patients applied clascoterone cream 1% twice daily to the entire face and, if desired by the patient and/or investigator, truncal acne, for up to 9 months. Patients achieving Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) could stop treatment and resume if/when acne worsened. Safety was assessed from treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs [telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus]) in all treated patients. Efficacy was assessed from IGA at each visit among those completing the study per-protocol (PP); face and trunk were evaluated individually.  Results: Of 600 patients aged ≥ 12 years (original randomization: 311 clascoterone, 289 vehicle), 343 completed the extension study (177 clascoterone, 166 vehicle). There were 187 TEAEs in 108/598 clascoterone-treated patients (18.1%), including 56/311 (18.0%) and 52/287 (18.1%) patients originally randomized to clascoterone and vehicle, respectively; the most common LSRs (previous clascoterone/vehicle) were erythema (face, 8.0%/7.7%) and scaling/dryness (face, 10.0%/7.3%). The percentage of PP patients with facial and truncal IGA 0/1 increased to 48.9% (156/319) and 52.4% (65/124), respectively, at study end. CONCLUSIONS: Clascoterone cream 1% maintained a favorable safety and efficacy profile for up to 12 months in patients aged ≥ 12 years. Eichenfield LF, Hebert AA, Stein Gold L, et al. Long-term safety and efficacy of twice-daily topical clascoterone cream 1% in patients ≥ 12 years of age with acne vulgaris. J Drugs Dermatol. 2023;22(8):810-816. doi:10.36849/JDD.7592.

Individual Article: Clascoterone Cream 1%: Mechanism of Action, Efficacy, and Safety of a Novel, First-in-Class Topical Antiandrogen Therapy for Acne.

Acne is a prevalent chronic inflammatory disease that can cause severe psychiatric effects and physical scarring of the skin. Historically, although systemic antiandrogen acne medications have been effective in women, the utility of these systemic medications has been limited due to potential systemic side effects in men and pregnant women. Therefore, research has been focused on developing topical formulations of antiandrogen therapy for acne. Topical clascoterone cream 1% is the first topical anti-androgen medication approved for the treatment of acne vulgaris in patients 12 years and older and represents a breakthrough in acne treatment. Clascoterone, or cortexolone-17α propionate, is an androgen receptor inhibitor with highly localized activity. Thismedication is thought to compete with dihydrotestosterone (DHT) for androgen receptors located in pilosebaceous units, thus inhibiting the acnegenic downstream effects of DHT such as lipid synthesis and inflammatory cytokine production in a dose-dependent manner. Two phase III clinical trials have been conducted thus far; both trials have shown clascoterone 1% cream applied BID to be significantly more effective than placebo cream at treating acne vulgaris in patients ages 12 and older with moderate-to-severe acne. Clascoterone has also been shown to have a similar safety profile to that of placebo cream in clinical studies, without any systemic antiandrogenic effects observed in the clinical setting. Due to its novel mechanism of action and activity limited to the skin, clascoterone presents an exciting opportunity for dermatologists to further optimize care for eligible acne patients, either as a monotherapy or in combination with other anti-acne medications. J Drugs Dermatol. 2023;22:56(Suppl 1):s7-14.

Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo.

BACKGROUND: Vitiligo is a chronic autoimmune disease that causes skin depigmentation. A cream formulation of ruxolitinib (an inhibitor of Janus kinase 1 and 2) resulted in repigmentation in a phase 2 trial involving adults with vitiligo. METHODS: We conducted two phase 3, double-blind, vehicle-controlled trials (Topical Ruxolitinib Evaluation in Vitiligo Study 1 [TRuE-V1] and 2 [TRuE-V2]) in North America and Europe that involved patients 12 years of age or older who had nonsegmental vitiligo with depigmentation covering 10% or less of total body-surface area. Patients were randomly assigned in a 2:1 ratio to apply 1.5% ruxolitinib cream or vehicle control twice daily for 24 weeks to all vitiligo areas on the face and body, after which all patients could apply 1.5% ruxolitinib cream through week 52. The primary end point was a decrease (improvement) of at least 75% from baseline in the facial Vitiligo Area Scoring Index (F-VASI; range, 0 to 3, with higher scores indicating a greater area of facial depigmentation), or F-VASI75 response, at week 24. There were five key secondary end points, including improved responses on the Vitiligo Noticeability Scale. RESULTS: A total of 674 patients were enrolled, 330 in TRuE-V1 and 344 in TRuE-V2. In TRuE-V1, the percentage of patients with an F-VASI75 response at week 24 was 29.8% in the ruxolitinib-cream group and 7.4% in the vehicle group (relative risk, 4.0; 95% confidence interval [CI], 1.9 to 8.4; P<0.001). In TRuE-V2, the percentages were 30.9% and 11.4%, respectively (relative risk, 2.7; 95% CI, 1.5 to 4.9; P<0.001). The results for key secondary end points showed superiority of ruxolitinib cream over vehicle control. Among patients who applied ruxolitinib cream throughout 52 weeks, adverse events occurred in 54.8% in TRuE-V1 and 62.3% in TRuE-V2; the most common adverse events were application-site acne (6.3% and 6.6%, respectively), nasopharyngitis (5.4% and 6.1%), and application-site pruritus (5.4% and 5.3%). CONCLUSIONS: In two phase 3 trials, application of ruxolitinib cream resulted in greater repigmentation of vitiligo lesions than vehicle control through 52 weeks, but it was associated with acne and pruritus at the application site. Larger and longer trials are required to determine the effect and safety of ruxolitinib cream in patients with vitiligo. (Funded by Incyte; TRuE-V1 and TRuE-V2 ClinicalTrials.gov numbers, NCT04052425 and NCT04057573.).

Dermal Safety of Tapinarof Cream 1%: Results From 4 Phase 1 Trials.

BACKGROUND: Tapinarof (VTAMA®; Dermavant Sciences, Inc.) is a novel, non-steroidal, topical, aryl hydrocarbon receptor agonist, FDA approved for psoriasis treatment and under investigation for atopic dermatitis treatment as a 1% cream formulation for once-daily (QD) application. OBJECTIVE: Evaluate cumulative skin irritation, sensitization, and photoallergic and phototoxic potential of tapinarof cream 1% across a range of dosing frequencies and conditions. METHODS: We conducted 4 randomized, controlled, phase 1 trials of topical tapinarof cream 1% vs vehicle or other appropriate controls in healthy adults. Cumulative skin irritation was assessed following QD application for 21 days under fully occlusive patch conditions. Contact sensitization, photoallergenicity, and phototoxicity were assessed under semi-occlusive patch conditions. The contact sensitization and photoallergenicity trials used an induction phase of repeated applications followed by a 2-week rest period and a 1-time challenge, with rechallenge if responses indicated sensitization/photosensitization; the phototoxicity trial comprised a single application. Ultraviolet A and B irradiation was used to assess photoallergenicity/toxicity. RESULTS: 376 participants were randomized across the 4 trials. In the cumulative irritation trial, tapinarof cream 1% QD was classified as having a slight potential for very mild cumulative irritation under the exaggerated test conditions of repeated dosing for 21 days. There was no evidence of sensitization, photosensitization, or phototoxicity. Tapinarof was well tolerated and there was a low discontinuation rate across all trials. CONCLUSIONS: Tapinarof cream 1% was well tolerated, non-sensitizing, non-phototoxic, and non-photoallergic, with no evidence of clinically meaningful cumulative skin irritation in 4 dermal safety trials in healthy adults. TRIAL REGISTRATION: IND 104601 J Drugs Dermatol. 2022;21(10):1084-1090. doi:10.36849/JDD.6627R1.

Efficacy and Safety of Tazarotene 0.045% Lotion in Caucasian Adults With Moderate-to-Severe Acne.

BACKGROUND: While topical retinoids are a mainstay of acne treatment, acne can manifest differently in various skin types. The objective of these post hoc analyses from two pooled phase 3 studies was to examine efficacy and safety of tazarotene 0.045% and quality of life improvements in self-identified Caucasian adults with moderate-to-severe acne. METHODS: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants aged ≥9 years with moderate-to-severe acne were randomized (1:1) to tazarotene 0.045% lotion or vehicle lotion (N=1,614); a subset of adults (≥18 years) who self-reported Caucasian (White) race (n=645) were examined. Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment (endpoint) success (≥2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 0 [clear] or 1 [almost clear]). Quality of life, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability were also assessed. RESULTS: At week 12, tazarotene lotion significantly reduced lesion counts by ~60% (least-squares mean percent changes from baseline, tazarotene vs vehicle: inflammatory, -61.2% vs -51.1%; noninflammatory, -59.7% vs -49.3%; P<0.001, both). Significantly more participants achieved treatment success with tazarotene lotion versus vehicle (P<0.001). Numerical improvements in quality-of-life domains were observed from baseline to week 12. Most TEAEs were unrelated to treatment, and rates of moderate-to-severe erythema decreased from baseline to week 12 with tazarotene treatment. CONCLUSIONS: Tazarotene 0.045% lotion was efficacious and well tolerated over 12 weeks and led to quality-of-life improvements in Caucasian adults with moderate-to-severe acne. These results, along with those from patients with skin of color, demonstrate that once daily tazarotene 0.045% lotion is an effective and well-tolerated treatment option regardless of race or skin color.J Drugs Dermatol. 2022;21(10):1061-1069. doi:10.36849/JDD.6834.

Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials.

Importance: Once-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis. Objective: To evaluate the efficacy of roflumilast cream, 0.3%, applied once daily for 8 weeks in 2 trials of patients with plaque psoriasis. Design, Setting, and Participants: Two phase 3, randomized, double-blind, controlled, multicenter trials (DERMIS-1 [trial 1; n = 439] and DERMIS-2 [trial 2; n = 442]) were conducted at 40 centers (trial 1) and 39 centers (trial 2) in the US and Canada between December 9, 2019, and November 16, 2020, and between December 9, 2019, and November 23, 2020, respectively. Patients aged 2 years or older with plaque psoriasis involving 2% to 20% of body surface area were enrolled. The dates of final follow-up were November 20, 2020, and November 23, 2020, for trial 1 and trial 2, respectively. Interventions: Patients were randomized 2:1 to receive roflumilast cream, 0.3% (trial 1: n = 286; trial 2: n = 290), or vehicle cream (trial 1: n = 153; trial 2: n = 152) once daily for 8 weeks. Main Outcomes and Measures: The primary efficacy end point was Investigator Global Assessment (IGA) success (clear or almost clear status plus ≥2-grade improvement from baseline [score range, 0-4]) at week 8, analyzed using a Cochran-Mantel-Haenszel test stratified by site, baseline IGA score, and intertriginous involvement. There were 9 secondary outcomes, including intertriginous IGA success, 75% reduction in Psoriasis Area and Severity Index (PASI) score, and Worst Itch Numeric Rating Scale score of 4 or higher at baseline achieving 4-point reduction (WI-NRS success) at week 8 (scale: 0 [no itch] to 10 [worst imaginable itch]; minimum clinically important difference, 4 points). Results: Among 881 participants (mean age, 47.5 years; 320 [36.3%] female), mean IGA scores in trial 1 were 2.9 [SD, 0.52] for roflumilast and 2.9 [SD, 0.45] for vehicle and in trial 2 were 2.9 [SD, 0.48] for roflumilast and 2.9 [SD, 0.47]) for vehicle. Statistically significantly greater percentages of roflumilast-treated patients than vehicle-treated patients had IGA success at week 8 (trial 1: 42.4% vs 6.1%; difference, 39.6% [95% CI, 32.3%-46.9%]; trial 2: 37.5% vs 6.9%; difference, 28.9% [95% CI, 20.8%-36.9%]; P < .001 for both). Of 9 secondary end points, statistically significant differences favoring roflumilast vs vehicle were observed for 8 in trial 1 and 9 in trial 2, including intertriginous IGA success (71.2% vs 13.8%; difference, 66.5% [95% CI, 47.1%-85.8%] and 68.1% vs 18.5%; difference, 51.6% [95% CI, 29.3%-73.8%]; P < .001 for both), 75% reduction in PASI score (41.6% vs 7.6%; difference, 36.1% [95% CI, 28.5%-43.8%] and 39.0% vs 5.3%; difference, 32.4% [95% CI, 24.9%-39.8%]; P < .001 for both), WI-NRS success (67.5% vs 26.8%; difference, 42.6% [95% CI, 31.3%-53.8%] and 69.4% vs 35.6%; difference, 30.2% [95% CI, 18.2%-42.2%]; P < .001 for both). The incidence of treatment-emergent adverse events was 25.2% with roflumilast vs 23.5% with vehicle in trial 1 and 25.9% with roflumilast vs 18.4% with vehicle in trial 2. The incidence of serious adverse events was 0.7% with roflumilast vs 0.7% with vehicle in trial 1 and 0% with roflumilast vs 0.7% with vehicle in trial 2. Conclusions and Relevance: Among patients with chronic plaque psoriasis, treatment with roflumilast cream, 0.3%, compared with vehicle cream resulted in better clinical status at 8 weeks. Further research is needed to assess efficacy compared with other active treatments and to assess longer-term efficacy and safety. Trial Registration: ClinicalTrials.gov Identifiers: NCT04211363, NCT04211389.

Efficacy and Tolerability of a Retinoid Eye Cream for Fine to Moderate Wrinkles of the Periorbital Region.

INTRODUCTION: The periorbital region is susceptible to premature skin aging and among the first areas to manifest age-related changes. Retinoids are highly effective but can be irritating, limiting use in this vulnerable area. A hydrating formulation comprised of a double-conjugated retinoid/alpha hydroxy acid (lactic acid; AHARet-EM) has been developed to address photoaging of the periorbital area. This study evaluated the efficacy, tolerability, and subject satisfaction of nightly application of AHARet-EM, and a regimen that included application of a peptide-rich eye cream (InF-E; AM) and AHARet-EM (PM). DESIGN: A 12-week, dual-center, open-label study evaluated nightly application of AHARet-EM in subjects 35 to 65 years of age with fine to moderate lines/wrinkles in the periorbital area (3-7 score based on the Fitzpatrick Classification Wrinkle Scale [FCWS]). A subset of subjects applied AHARet-EM (PM) and InF-E (AM). Investigator assessments at baseline and weeks 4, 8, and 12 were based on the 9-point FCWS for lines/wrinkles (1 [Fine Wrinkles] to 9 [Deep Wrinkles]) and a 6-point scale (0 [None] to 5 [Severe]) for texture, erythema, and under-eye darkness, puffiness, and dryness. Subject satisfaction and adverse events (AEs) were captured over 12 weeks. RESULTS: Twenty-six subjects, Fitzpatrick skin type III-VI, completed the study. Subjects applying AHARet-EM (n=16) demonstrated significant improvements from baseline at week 12 in the appearance of lines/wrinkles (33%; P<.0001), texture (37%, P<.0001), erythema (37%, P=.004), under-eye darkness (41%; P<.001), puffiness (55%, P<.0001) and dryness (94%, P<.0001). Significant improvements from baseline were demonstrated in subjects using the AM/PM regimen (n=10) at week 12 in the appearance of texture (33%; P=.002), erythema (68%; P=.001), under-eye darkness (32%; P=.007), puffiness (64%; P=.01) and dryness (90%; P<.0001). No AEs occurred related/possibly related to use of the study products. High levels of subject satisfaction were reported over 12 weeks. CONCLUSION: Nightly application of a hydrating, double-conjugated retinoid eye cream demonstrated significant improvements in the appearance of lines/wrinkles, under-eye darkness, puffiness, and dryness of the periorbital area at week 12. Morning application of a peptide-rich eye cream afforded additional benefits. The study products were non-irritating, and subjects reported high levels of satisfaction throughout the study. J Drugs Dermatol. 2022;21(9):932-937. doi:10.36849/JDD.6815.

Vehicle Formulation Impacts Tolerability and Patient Preference: Comparison of Tretinoin Branded Lotion and Generic Cream.

BACKGROUND: Topical retinoids like tretinoin are a mainstay of acne treatment but associated cutaneous irritation and drying may lead to poor adherence. As vehicle optimization can improve patient preference and adherence, tretinoin 0.05% lotion (Altreno®) was formulated using polymeric emulsion technology for uniform delivery of micronized tretinoin and moisturizing/hydrating excipients. This study compared tolerability and participant preference of a branded tretinoin 0.05% lotion versus generic cream. METHODS: In this single-center, double-blind, split-face study, 25 adult females with acne were randomized to apply lotion and cream to opposite cheeks once daily for 2 weeks. Investigator-assessed skin irritation and appearance, as well as participant ratings of the products and skin sensations, were evaluated immediately after first use and after 2 weeks. RESULTS: At week 2, there was significantly greater erythema, scaling, and dryness (122%–144%; P<0.01 each) and decreased skin softness, smoothness, radiance, and brightness (~40% difference; P<0.01 each) on the cream-treated versus lotion-treated side of the face. More participants agreed that the lotion was gentle, comfortable/soothing, spreadable, absorbent, not sticky, and left minimal residue versus cream (range: 72%–92% vs 8%–36%). Agreement scores on skin sensations (eg, soft, not dry, less dull) were similarly higher for lotion versus cream. Overall, ~70% of participants preferred to take home the lotion over the cream. CONCLUSIONS: After 2 weeks of once-daily use, tretinoin 0.05% lotion was associated with less irritation and superior skin appearance/ sensation versus generic 0.05% cream, with most participants preferring the lotion over cream. These results demonstrate the importance of a well-designed vehicle formulation on tolerability and patient preference. J Drugs Dermatol. 2022;21(8): 875-880. doi:10.36849/JDD.6945.

Efficacy and tolerability of a novel skin cream for improving periocular rhytids and dryness.

OBJECTIVE: A novel topical cream was developed to address the appearance of aging periorbital skin. The goal of this study was to evaluate the efficacy and tolerability of this product (Total Eye® Firm & Repair Cream; Colorescience, Inc., Carlsbad, CA) for improving periorbital wrinkles, dryness, laxity, and dark circles. METHODS: This 8-week open-label trial enrolled subjects 35-65 years old seeking periocular rejuvenation (N = 25; 22 female, 3 male). The product was applied each morning and evening after facial cleansing. Study endpoints were changes in Investigator Clinical Grading and Eye Appearance Assessments, Subject Self-assessment Questionnaires, and tolerability after 4 and 8 weeks of treatment. RESULTS: Among subjects completing the study (n = 23), all (100%) showed some global improvement at Weeks 4 and 8 and almost half (48%) achieved moderate or marked improvement. Improvements were observed for all parameters and were most pronounced for wrinkles, laxity, and dark circles. Improvements for laxity and dryness were significant by Week 4 and for dark circles by Week 8. At Week 8, subjects agreed or strongly agreed that the product made their eyes feel more hydrated (100%), look and feel healthier (95%), and increased confidence in their eye appearance (91%). The product was well-tolerated. LIMITATIONS: Modest number of subjects and open-label study design. CONCLUSION: Twice-daily Total Eye® Firm & Repair Cream improved the overall appearance of the periorbital area. The product was well-tolerated and most treated subjects were satisfied with their results. The product is a viable option for treating periorbital wrinkles and laxity and should be considered a safe and effective skincare option.

Tazarotene 0.045% Lotion for Females With Acne: Analysis of Two Adult Age Groups.

BACKGROUND: Females aged ≥25 years may have acne with different etiology, presentation, burden, and treatment response than females 18–24 years. This post hoc analysis investigated efficacy and safety of tazarotene 0.045% lotion in females ≥18 years or ≥25 years of age. METHODS: In two phase 3 double-blind studies, participants 9 years of age and older with moderate-to-severe acne were randomized (1:1) to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Pooled data were analyzed for females aged ≥18 years (n=744) or ≥25 years (n=335). Assessments included inflammatory/noninflammatory lesion counts, treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and score of 0 [clear] or 1 [almost clear]), Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability. RESULTS: At week 12, tazarotene-treated females in both age groups had greater reductions from baseline versus vehicle in inflammatory (≥18 years: 60.6% vs 53.7% [P<0.01]; ≥25 years: 60.9% vs 57.3% [P>0.05]) and noninflammatory lesions (59.0% vs 48.4% and 61.1% vs 48.8%; P<0.01, both). Rates of treatment success were greater with tazarotene versus vehicle; this difference was significant for females ≥18 years. Acne-QoL improvements were similar across age groups and generally greater with tazarotene than vehicle. TEAEs were mostly mild to moderate in severity. No age-related trends for safety or tolerability were observed. CONCLUSIONS: Tazarotene 0.045% lotion demonstrated comparable efficacy, improvement in quality of life, and safety in adult females aged ≥18 or ≥25 years with moderate-to-severe acne. This cosmetically elegant lotion is a well-studied and important treatment option for all patients, particularly adult females. J Drugs Dermatol. 2022;21(5):587-595. doi:10.36849/JDD.6876.

Advances in Topical Management of Adolescent Facial and Truncal Acne: A Phase 3 Pooled Analysis of Safety and Efficacy of Trifarotene 0.005% Cream.

PURPOSE: Acne vulgaris is very common among adolescents and young adults. It is important for clinicians who provide care to these patients to have a plan of action for assessing and managing acne in daily practice. METHODS: Post-hoc analysis of two large-scale phase 3 pivotal trials of trifarotene 0.005% cream, focusing on efficacy, safety, and tolerability in the subgroup of subjects aged 12 to 17, inclusive. RESULTS: Trifarotene was effective and well tolerated on both the face and trunk in patients ages 12-17 with moderate acne. There was a low and acceptable rate of adverse events and tolerability was favorable. CONCLUSIONS: Trifarotene monotherapy was associated with good clinical efficacy, safety, and tolerability. Once-daily application offers convenience for patients, and the low concentration of trifarotene makes it well-suited to use on large skin areas such as the trunk. J Drugs Dermatol. 2022;21(6):582-586. doi:10.36849/JDD.6778.