NCT02749383已完成2 期
A Randomized, Double-blind, Single Center, Investigator-initiated Clinical Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Subjects With Mild to Moderate Seborrheic Dermatitis of the Face
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Treatment success rate in IGE(Investigator's Global Evaluation)
研究概览
简要总结
This study is a Phase II, single center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of the face. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 19 and 65 years old
- •Clinical diagnosis of seborrheic dermatitis in the facial area with Erythema severity ≥ 2 and Scaling severity ≥ 2
- •IGE (Investigator's Global Evaluation) Score 2 or 3
排除标准
- •Patients with psoriasis, atopic dermatitis, facial acne, rosacea or perioral dermatitis
- •Patients who have been infected with bacteria, fungi, virus and animal infectious disease on the facial area
- •Patients who were administered topical antifungal agents, steroids, retinoids, or calcineurin suppressants for the treatment of seborrheic dermatitis within the last 2 weeks
- •Patients who were administered systemic antifungal agents, steroids, retinoids, or immunosuppressants for the treatment of seborrheic dermatitis within the last 4 weeks
- •Patients who were administered local antibiotics for the treatment of seborrheic dermatitis within the last 4 weeks
- •Pregnant women, breastfeeding women or women of childbearing potential or women who are planning a pregnancy during the study
研究组 & 干预措施
PAC-14028 cream vehicle
Placebo Comparator
Twice daily for 4 weeks
干预措施: PAC-14028 cream vehicle (Drug)
PAC-14028 cream 0.3%
Experimental
Twice daily for 4 weeks
干预措施: PAC-14028 cream 0.3% (Drug)
PAC-14028 cream 1.0%
Experimental
Twice daily for 4 weeks
干预措施: PAC-14028 cream 1.0% (Drug)
结局指标
主要结局
Treatment success rate in IGE(Investigator's Global Evaluation)
时间窗: Change from Baseline at Day 14 and Day 28
Treatment success rate in IGE on 28th day from the baseline
次要结局
- Change in Visual Analogue Scale(VAS) score(Change from baseline at Day 14 and 28)
- Change in Erythema severity score(Change from baseline at Day 14 and 28)
- Change in Scale severity score(Baseline, Day 14 and Day 28)
研究者
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