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Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug.
Stein Gold, L, Baldwin, H, Kircik, LH, Weiss, JS, Pariser, DM, Callender, V, Lain, E, Gold, M, Beer, K, Draelos, Z, et al
American journal of clinical dermatology. 2022;(1):93-104
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Abstract
BACKGROUND A three-pronged approach to acne treatment-combining an antibiotic, antibacterial, and retinoid-could provide greater efficacy and tolerability than single or dyad treatments, while potentially improving patient compliance and reducing antibiotic resistance. OBJECTIVES We aimed to evaluate the efficacy and safety of triple-combination, fixed-dose topical clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) gel for the treatment of acne. METHODS In a phase II, double-blind, multicenter, randomized, 12-week study, eligible participants aged ≥ 9 years with moderate-to-severe acne were equally randomized to once-daily IDP-126, vehicle, or one of three component dyad gels: BPO/adapalene; clindamycin phosphate/BPO; or clindamycin phosphate/adapalene. Coprimary endpoints were treatment success at week 12 (participants achieving a ≥ 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin) and least-squares mean absolute changes from baseline in inflammatory and noninflammatory lesion counts to week 12. Treatment-emergent adverse events and cutaneous safety/tolerability were also assessed. RESULTS A total of 741 participants were enrolled. At week 12, 52.5% of participants achieved treatment success with IDP-126 vs vehicle (8.1%) and dyads (range 27.8-30.5%; P ≤ 0.001, all). IDP-126 also provided significantly greater absolute reductions in inflammatory (29.9) and noninflammatory (35.5) lesions compared with vehicle or dyads (range inflammatory, 19.6-26.8; noninflammatory, 21.8-30.0; P < 0.05, all), corresponding to > 70% reductions with IDP-126. IDP-126 was well tolerated, with most treatment-emergent adverse events of mild-to-moderate severity. CONCLUSIONS Once-daily treatment with the novel fixed-dose triple-combination clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15% gel demonstrated superior efficacy to vehicle and all three dyad component gels, and was well tolerated over 12 weeks in pediatric, adolescent, and adult participants with moderate-to-severe acne. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov identifier NCT03170388 (registered 31 May, 2017).
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Topical 2% ketoconazole cream monotherapy significantly improves adult female acne: A double-blind, randomized placebo-controlled trial.
Chottawornsak, N, Chongpison, Y, Asawanonda, P, Kumtornrut, C
The Journal of dermatology. 2019;(12):1184-1189
Abstract
The emergence of bacterial resistance is a global crisis. Prolonged use of antibiotics especially in acne is one issue of concern among dermatologists. Ketoconazole (KTZ) cream, a topical antifungal with anti-inflammatory and antiandrogenic actions, can decrease lipase activity of Cutibacterium acnes in vitro. We evaluated the efficacy and safety of KTZ cream in mild adult female acne (AFA) by conducting a randomized, double-blind, placebo-controlled trial using KTZ 2% and placebo cream twice daily for 10 weeks. We assessed the improvement of clinical severity, measured by AFA score graded by investigators and participants, and the change of acne count. Forty-one participants enrolled in our study. The proportion of participants with acne improvement from baseline (42.9% vs 9.5%, P = 0.015) and the success rate (45.0% vs 14.3%, P = 0.043) in the KTZ group were significantly higher than that of the placebo group. The most common adverse events were dryness and itching. The percentage change of acne count decreased significantly compared with baseline but did not differ statistically between the two groups (P = 0.268). We concluded that the KTZ monotherapy showed a plausible effect in improving AFA with excellent safety profile. It should be considered as a viable option for mild AFA treatment.
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Efficacy and safety of moisturizer containing 5% panthenol, madecassoside, and copper-zinc-manganese versus 0.02% triamcinolone acetonide cream in decreasing adverse reaction and downtime after ablative fractional carbon dioxide laser resurfacing: A split-face, double-blinded, randomized, controlled trial.
Lueangarun, S, Srituravanit, A, Tempark, T
Journal of cosmetic dermatology. 2019;(6):1751-1757
Abstract
INTRODUCTION Fractional carbon dioxide (FrCO2 ) laser is effective for atrophic acne scar treatment, but unavoidable downtime. Meanwhile, postoperative topical steroid decreases the downtime, yet still possibly increases other steroid side effects. OBJECTIVE To evaluate the efficacy and safety of moisturizer containing 5% panthenol, madecassoside, and copper-zinc-manganese (experimental cream) versus 0.02% Triamcinolone acetonide (TA) cream in decreasing adverse effects and downtime after FrCO2 laser, with wound healing improvement and prevention of certain steroid-related side effects like postinflammatory hyperpigmentation (PIH). METHODS We conducted a double-blinded, split face, randomized controlled trial in 20 subjects receiving FrCO2 laser on both sides of the faces and randomly treated with two posttreatment regimens on each side for 7 days. Clinical, expert panel assessment of photography, downtime, side effects, and biometric evaluation for erythema and melanin were performed on baseline, immediately after treatment, day 3, 5, 7, 14, 30 and, 60 postoperatively. RESULTS Both experimental cream (EC) and 0.02% TA cream could significantly reduce postlaser downtime including swelling, redness, crusting, and scaling in 5-7 days, with comparable efficacies in decreasing downtime and adverse reactions, as well as wound healing improvement and lower PIH without statistically significant difference between the two treatments. The incidence of PIH was 60% in the EC treated group with minimal intensity. CONCLUSION The moisturizer with anti-inflammatory ingredients could be a novel treatment modality for reduction of postablative laser downtime by using nonsteroidal anti-inflammatory agents to avoid adverse effects and improve wound healing process with lower PIH.
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Efficacy and safety of 2% supramolecular salicylic acid compared with 5% benzoyl peroxide/0.1% adapalene in the acne treatment: a randomized, split-face, open-label, single-center study.
Zheng, Y, Yin, S, Xia, Y, Chen, J, Ye, C, Zeng, Q, Lai, W
Cutaneous and ocular toxicology. 2019;(1):48-54
Abstract
BACKGROUND Topical drugs for mild to moderate acne include adapalene (ADA) and benzoyl peroxide(BPO). Supramolecular salicylic acid (SSA), a modified SA preparation, is considered as a new effective therapeutic scheme. OBJECTIVES To compare the safety and efficacy of 2% supramolecular SA (2% SSA) with 0.01% adapalene plus 5% benzoyl peroxide (5%BPO +0.1%ADA) for treatment of facial acne. MATERIALS AND METHODS This was an open-label, split face, randomized and single-centre clinical trial. Subjects with mild to moderate acne were enrolled. Two percent SSA cream were randomly applied on one side of the face while 5%BPO +0.1%ADA gel was applied on the opposite side for 28 days. The numbers of acne lesions, along with side effects of the targeted area were evaluated by the investigators at day 0, day 14, and day 28. Skin water content, TEWL and skin lightening indexes were measured at the same time. RESULTS A total of 31 of acne patients completed the trial. Dates showed that 2% SSA had similar effects to 5%BPO +0.1%ADA in reducing papules/pustules (47.9% vs. 49.8%), non-inflammatory lesions (43.1% vs. 42.7%) and total lesions (44.1% vs. 45.6%; all p > 0.05) at day 28. The skin barrier (skin hydration value and TEWL value), skin brightness (L* value) and erythema (a* values) indicators showed no statistical differences in the left and right sides of the face (p > 0.05). CONCLUSION This study demonstrated that 2% SSA has a similar efficacy with 5%BPO +0.1%ADA in mild to moderate acne treatment. This might be a useful pilot study that could be used to support further larger clinical trials.