DMT310, a novel once-weekly topical treatment for patients with moderate-to-severe acne vulgaris: Results of a phase 2b randomized, double-blind, placebo-controlled trial

医学 安慰剂 耐受性 痤疮 不利影响 临床试验 随机化 随机对照试验 内科学 人口 疾病严重程度 皮肤病科 病理 替代医学 环境卫生
作者
Lawrence F. Eichenfield,Janet DuBois,Michael H. Gold,Christopher Nardo,Zoe Diana Draelos,E. Armas,Oscar DeValle,Robert S. Haber,Terry Jones,Steve Kempers,Theresa Greene Knoepp,B.J. Kuttner,Randy Lieberman,Michelle Miller,Daniel Stewart,Julius Weinberg
出处
期刊:Journal of The American Academy of Dermatology [Elsevier BV]
卷期号:89 (5): 945-951 被引量:1
标识
DOI:10.1016/j.jaad.2023.05.070
摘要

Poor patient adherence with antiacne medications is a common clinical challenge. DMT310, a natural, topical product with a once-weekly application schedule, may alleviate this obstacle.Evaluate the safety, tolerability, and efficacy of DMT310 in treating moderate-to-severe acne.This 12-week, randomized, double-blind, placebo-controlled, multicenter clinical trial enrolled participants 12 years and older with moderate-to-severe acne.The intent-to-treat population included a total of 181 participants (DMT310, N = 91; placebo, N = 90). Participants who received DMT310 vs participants treated with placebo demonstrated a statistically significant greater reduction in the number of inflammatory and noninflammatory lesions at all time points: inflammatory lesion counts at week 12 (-15.64 vs -10.84, P < .001); noninflammatory lesion counts at week 12 (-18.26 vs -12.41, P < .001). DMT310-treated participants also had higher rates of Investigator's Global Assessment treatment success than participants in the placebo group at all time points: Investigator's Global Assessment at week 12 (44.40% vs 17.78%; P < .001). No serious treatment related adverse events occurred.DMT310 once-weekly topical treatment significantly reduced both inflammatory and noninflammatory lesions and yielded a greater proportion of Investigator's Global Assessment treatment success at all time points in participants with moderate-to-severe acne.
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