Double-blinded, Single-center, Parallel-arm Comparison Study of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Global Photodamage Severity
研究概览
简要总结
The purpose of this study is to assess the comparative efficacy of retinol 1.0% and tretinoin 0.02% in minimizing wrinkles, discoloration, roughness, and other signs of moderate to severe photodamage. Our hypothesis is that both products will be of comparable benefit.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 35 or over
- •Moderate to severe photodamage
排除标准
- •History of facial cosmetic surgery, facial resurfacing procedures, deep peels, or facial fillers
- •History of keloids or hypertrophic scars
- •Use of oral steroids or oral retinoids (such as Accutane) in past 6 months
研究组 & 干预措施
Retinol
Retinol 1.0% cream
干预措施: Retinol (Drug)
Tretinoin
Tretinoin 0.02% cream
干预措施: Tretinoin (Drug)
结局指标
主要结局
Global Photodamage Severity
时间窗: Week 24
A photonumeric scale for the assessment of cutaneous photodamage (CE Griffiths, et al). Five photographic standards (en face and 45 degrees oblique) illustrating increasing severity of photodamage (min=0, max=8) where 0=no damamge; 2=mild damage; 4=moderate damage; 6=moderate/severe damage; and grade 8=severe damage.
次要结局
未报告次要终点
研究者
Anna Chien
Assistant Professor
Johns Hopkins University