[Translation] A multicenter, randomized, double-blind, three-arm, parallel, placebo-controlled clinical trial to evaluate the efficacy and safety of vefluquinone cream in the treatment of moderate to 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] Primary objective: To evaluate the efficacy and safety of fluocinolone cream in the treatment of moderate to severe chloasma.
Secondary objective: To evaluate the clinical equivalence of fluocinolone cream and the reference preparation by clinical endpoint method; to clarify the systemic exposure of the test preparation and the reference preparation by monitoring the systemic absorption of the three components of retinoic acid, fluocinolone acetonide and hydroquinone in clinical trials.