背景:联合抗生素治疗痤疮的三管齐下的方法,抗菌,和类维生素A可能比单/双治疗更有效,同时可能降低抗生素耐药性。本研究评估了首次固定剂量的疗效和安全性,三重组合外用痤疮产品,使用合并的3期数据,克林霉素1.2%/阿达帕林0.15%/过氧化苯甲酰(BPO)3.1%凝胶(CAB)。
方法:在两个相同的阶段3(N=183;N=180)中,双盲,12周的研究,年龄≥9岁的中度至重度痤疮患者接受2:1的随机分组,接受每日1次CAB或溶媒凝胶治疗.终点包括评估者总体严重程度评分和清晰/几乎清晰的皮肤(治疗成功)中与基线相比的≥2级减少,以及痤疮病变计数与基线相比的最小二乘平均百分比变化。评估治疗引起的不良事件(TEAE)和皮肤安全性/耐受性。
结果:在第12周时,50.0%的参与者使用CAB获得治疗成功,而使用载体凝胶获得22.6%(P<0.001)。在第12周,CAB导致炎性和非炎性病变减少>70%(77.9%和73.0%,分别),显着大于载体(57.9%和48.2%;P<0.001,两者)。大多数TEAE为轻度-中度严重程度,<3%的CAB治疗的参与者因AE而停止研究/治疗。缩放时从基线开始的瞬态增加,红斑,瘙痒,燃烧,用CAB观察到刺痛,但在第12周解决回到或接近基线值。
结论:创新的固定剂量,三组合克林霉素磷酸酯1.2%/阿达帕林0.15%/BPO3.1%凝胶在儿童中有效且耐受性良好,青少年,和患有中度至重度痤疮的成年人。一半的参与者在12周时达到了清晰/几乎清晰的皮肤,以前在其他外用痤疮产品的临床研究中没有看到的比率。
背景:ClinicalTrials.gov标识符NCT04214639和NCT04214652。
BACKGROUND: A three-pronged approach to acne treatment combining an antibiotic, antimicrobial, and
retinoid may be more efficacious than single/double treatments while potentially reducing antibiotic resistance. This study evaluated the efficacy and safety of the first fixed-dose, triple-combination topical acne product, clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) using pooled phase 3 data.
METHODS: In two identical phase 3 (N = 183; N = 180), double-blind, 12-week studies, participants aged ≥ 9 years with moderate-to-severe acne were randomized 2:1 to receive once-daily CAB or vehicle gel. Endpoints included ≥ 2-grade reduction from baseline in Evaluator\'s Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in acne lesion counts. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated.
RESULTS: At week 12, 50.0% of participants achieved treatment success with CAB versus 22.6% with vehicle gel (P < 0.001). CAB resulted in > 70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P < 0.001, both). Most TEAEs were of mild-moderate severity, and < 3% of CAB-treated participants discontinued study/treatment because of AEs. Transient increases from baseline in scaling, erythema, itching, burning, and stinging were observed with CAB, but resolved back to or near baseline values by week 12.
CONCLUSIONS: The innovative fixed-dose, triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel was efficacious and well tolerated in children, adolescents, and adults with moderate-to-severe acne. Half of participants achieved clear/almost clear skin by 12 weeks, rates not previously seen in clinical studies of other topical acne products.
BACKGROUND: ClinicalTrials.gov identifier NCT04214639 and NCT04214652.