[Translation] A multicenter, randomized, double-blind, placebo-controlled phase Ib study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of different concentrations of ZYG24002 emulsion in adult patients with mild to moderate seborrheic dermatitis.
主要目的:
安全性:评价 ZYG24002 乳液在三种浓度(0.5 %、0.75 %、1.0 %)每日 1 次(1.0 %)或 2 次(0.5 %、0.75 %、1.0 %)、连续 28 天局部给药及随访期间的不良事件、实验室相关指标、生命体征和心电图变化。
局部耐受性(LTS):评价给药部位的灼烧感、刺痛感、瘙痒、红斑、水肿/丘疹局部皮肤反应的发生率、严重程度。
次要目的:
药代动力学 (PK) 特征:单次给药后及稳态条件下的主要 PK 参数;比较不同浓度/给药频次下的系统暴露水平,评估剂量/频次依赖性与蓄积倾向。
初步有效性探索:观察不同浓度及给药频次连续局部用药后,对脂溢性皮炎总体评估(IGA-SD )治疗成功率、最严重瘙痒强度(WI-NRS)、皮肤病生活质量指数(DLQI)疗效指标的影响。
[Translation] Primary Objectives:
Safety: To evaluate adverse events, laboratory parameters, vital signs, and ECG changes of ZYG24002 emulsion at three concentrations (0.5%, 0.75%, 1.0%), administered once daily (1.0%) or twice daily (0.5%, 0.75%, 1.0%) for 28 consecutive days of topical administration and during follow-up.
Local Tolerability (LTS): To evaluate the incidence and severity of local skin reactions at the administration site, including burning, stinging, itching, erythema, and edema/papules.
Secondary Objectives:
Pharmacokinetic (PK) Characteristics: To determine the primary PK parameters after a single dose and under steady-state conditions; to compare systemic exposure levels at different concentrations/dosage frequencies; and to assess dose/frequency dependence and accumulation tendency.
Preliminary efficacy exploration: Observe the effects of continuous topical application of different concentrations and frequencies on the overall assessment of seborrheic dermatitis (IGA-SD) treatment success rate, most severe pruritus intensity (WI-NRS), and dermatological quality of life index (DLQI) efficacy indicators.