[Translation] A multicenter, randomized, double-blind, three-arm, parallel, placebo-controlled clinical trial evaluating the efficacy and safety of vifluraquinone cream in the treatment of moderate and severe melasma
主要目的:评价维氟醌乳膏治疗中、重度黄褐斑的疗效和安全性。
次要目的:以临床终点方法评价维氟醌乳膏与参比制剂的临床等效性;通过监测临床试验中维A酸、氟轻松、氢醌三种成分的系统吸收,明确受试制剂与参比制剂的系统暴露情况。
[Translation] Main objective: To evaluate the efficacy and safety of retinoid cream in the treatment of moderate and severe melasma.
Secondary objective: To evaluate the clinical equivalence of retinoid cream and reference preparation by clinical end point method; by monitoring the systemic absorption of tretinoin, fluocinolone and hydroquinone in clinical trials, to clarify the relationship between test preparation and reference preparation. Systemic exposure of the reference product.