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临床试验/NCT01951417
NCT01951417已完成4 期

Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Pump Cetaphil® DermaControl™ Moisturizer SPF 30, and Cetaphil® DermaControl™ Foaming Wash Regimen in Patients With Mild to Moderate Acne Vulgaris

Galderma R&D5 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Galderma R&D
入组人数
81
试验地点
5
主要终点
Total Lesion Count

研究概览

简要总结

This is an open-label, multi-center study to be conducted in the United States. The study will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30 (once daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible for treatment with Epiduo® in accordance with the currently approved product labeling and who meet other inclusion/exclusion criteria are to be enrolled in the study and receive the study products for 8 weeks. Efficacy and safety assessments include: complete lesion counts, cutaneous irritation assessment, end of study treatment questionnaire, photographic evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function assessment, treatment compliance, and adverse event assessment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
9 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women of any race, 9 years or older, with a diagnosis of mild to moderate acne, who are eligible for treatment with adapalene BPO gel in accordance with the currently approved product labeling.

排除标准

  • Subjects with nodules and cysts, pregnant or breastfeeding, with any systemic or dermatological disorder, or topical condition or facial hair that could interfere with evaluations.

研究组 & 干预措施

Adapalene/BPO Gel/Foam Wash/Moisturizer

Experimental

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

干预措施: Adapalene/BPO Gel (Drug)

Adapalene/BPO Gel/Foam Wash/Moisturizer

Experimental

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

干预措施: Moisturizer SPF 30 (Other)

Adapalene/BPO Gel/Foam Wash/Moisturizer

Experimental

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

干预措施: Foam Wash (Other)

结局指标

主要结局

Total Lesion Count

时间窗: Baseline, 2, 4, and 8 weeks

The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.

次要结局

  • Non-inflammatory Lesions(Baseline, 2, 4, and 8 weeks)
  • Inflammatory Lesions(Baseline, 2, 4, and 8 weeks)
  • Subject Questionnaire(Baseline, 2, 4, and 8 weeks)

研究者

发起方
Galderma R&D
申办方类型
Industry
责任方
Sponsor

研究点 (5)

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