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临床试验/NCT01172522
NCT01172522已完成2 期

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

The Connecticut Sinus Center, PC1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Topical treatment active versus placebo.

Double blind randomized placebo controlled split face intrasubject comparison.

干预措施: Fexofenadine (Drug)

Fexofenadine left; placebo right

Experimental

Topical treatment active versus placebo.

Double blind randomized placebo controlled split face intrasubject comparison.

干预措施: Placebo (Drug)

Fexofenadine right; placebo left

Experimental

Split face double blind

干预措施: Fexofenadine (Drug)

Fexofenadine right; placebo left

Experimental

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

研究者

发起方
The Connecticut Sinus Center, PC
申办方类型
Other
责任方
Sponsor

研究点 (1)

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