A Pilot Randomized Double Blind Study to Assess the Safety and Efficacy of 1% Ibuprofen/ 1%Fexofenadine Topical Cream for the Treatment of Dark Circles Under the Eyes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention
研究概览
简要总结
This study examines topical treatment of under eye circles and swelling.
详细描述
This study examines topical treatment of under eyes dark circles and under eye swelling.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Under eye dark circles and swelling
排除标准
- •Under age 18
- •Allergy to tested medicines
研究组 & 干预措施
Fexofenadine left; placebo right
Topical treatment active versus placebo.
Double blind randomized placebo controlled split face intrasubject comparison.
干预措施: Fexofenadine (Drug)
Fexofenadine left; placebo right
Topical treatment active versus placebo.
Double blind randomized placebo controlled split face intrasubject comparison.
干预措施: Placebo (Drug)
Fexofenadine right; placebo left
Split face double blind
干预措施: Fexofenadine (Drug)
Fexofenadine right; placebo left
Split face double blind
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention
时间窗: Baseline, weekly, and end of study +7 days
Efficacy was measured per intervention by assessing number of participants with improvement in under eye dark circles and swelling. Criteria used to assess under eye improvement and swelling was by a 5 point scale comparing each week's photographic appearance to the appearance at baseline: 1) fexofenadine right and placebo left, and 2) fexofenadine left and placebo right. The split face comparison was noted in efficacy measured changes in under eye swelling and dark circles relative to baseline. Participants were graded by 2 blinded dermatologists who reviewed photographs of all participants at entry and weekly until end of study plus one week, day 37. Total number of participants: 30. Placebo right and fexofenadine left 15 participants. Placebo left and fexofenadine right 15 participants.
次要结局
未报告次要终点
