A Comparative Study of Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream, for the Treatment of Photodamage
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24
研究概览
简要总结
The primary purpose of this study is to compare the efficacy of adapalene (Differin®) gel 0.3% and tretinoin 0.05% emollient cream for the treatment of signs of photodamage, with tolerability assessment as a secondary objective.
详细描述
Same as above.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female aged 40 years of age and older with Fitzpatrick skin types I through III
- •Clinically moderate to severe photodamage
排除标准
- •Subjects with history of laser resurfacing, dermabrasion, medium or deep chemical peel of the face
- •Subjects with diagnosis of skin cancer within 3 months of study entry
- •Subjects who have had superficial chemical peels, exfoliation or microdermabrasion of the face within 3 months of study entry
- •Subjects who have had botulinum toxin for facial rejuvenation within 6 months of study entry and are unwilling to refrain from botulinum toxin treatments during the study
研究组 & 干预措施
adapalene
adapalene
干预措施: adapalene gel, 0.3% (Drug)
tretinoin
Tretinoin
干预措施: tretinoin 0.05% emollient cream (Drug)
结局指标
主要结局
Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24
时间窗: baseline to week 24
Number of participants who improved (a decrease by at least one point) in Overall Integrated Assessment of Photodamage from baseline to week 24. Overall Integrated Assessment of Photodamage is a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 - Moderate, 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.
次要结局
- Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24(week 12 and week 24)
- Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24(week 12 and week 24)
- Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12.(baseline to week 12)
- Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24(baseline, week 12 and week 24)