Effect of CD07805/47 Gel in Subjects Presenting With Flushing Related to Erythematotelangiectatic or Papulopustular Rosacea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Total Number of Flushes for Each 2-week Period
研究概览
简要总结
Phase 2a study to assess the efficacy and safety of CD07805/47 0.5% gel in the prevention of the flush of rosacea.
详细描述
The objectives of this study in rosacea patients (type I&II) are:
- to demonstrate objectively that CD07805/47 0.5% gel is able to prevent a flush induced by a specific trigger (hot water) in controlled condition;
- to demonstrate that CD07805/47 0.5% gel is able to prevent a flush whatever the trigger in everyday life condition;
- to investigate if reduction in redness is associated with a decrease in skin sensations such as heat, stinging/burning, skin tension and sweating;
- to demonstrate that such efficacy on transient redness and sensations takes place in both populations (rosacea type I and rosacea type II).
This is a single-centre, randomized, Investigator masked, placebo controlled study comprising the following periods:
A screening period of maximum 4 weeks
A one-week treatment phase (Period 1) with 3 sessions using the flush model, every other day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is a male or female, who is at least 18 years of age or older at Screening visit.
- •The subject has a clinical diagnosis of mild to moderate erythemato-telangiectatic rosacea or mild to moderate papulo-pustular rosacea according to the National Rosacea Society grading (Wilkin et al., 2004)
- •The subject had at least five flushing episodes during the last week before Screening and Baseline visits
排除标准
- •The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin), or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus or actinic telangiectasia;
- •The subject has current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists;
- •The subject has less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents;
研究组 & 干预措施
CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo
Period 1:
Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design)
Period 2 (cross-over design):
Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks
干预措施: CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo (Drug)
Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo
Period 1:
Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks.
干预措施: Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo (Drug)
CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47
Period 1:
Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.
干预措施: CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47 (Drug)
Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47
Period 1:
Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.
干预措施: Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47 (Drug)
结局指标
主要结局
Total Number of Flushes for Each 2-week Period
时间窗: Day 22 and Day 36/Early termination
次要结局
未报告次要终点