Topical Treatment of Under Eye Dark Circles and Swelling

Phase 2

Completed

• Conditions: Edema
• Interventions: Drug: Fexofenadine; Drug: Placebo

• Registration Number: NCT01172522
• Lead Sponsor: The Connecticut Sinus Center, PC

Brief Summary

This study examines topical treatment of under eye circles and swelling.

Detailed Description

This study examines topical treatment of under eyes dark circles and under eye swelling.

Study Timeline

• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-28
• Study First Posted: 2010-07-29
• Study Start: 2010-09
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Results First Submitted: 2014-02-03
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-16
• Last Update Submitted: 2015-02-16
• Results First Posted: 2015-02-19
• Last Update Posted: 2015-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Under eye dark circles and swelling

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Exclusion Criteria

• Under age 18
• Allergy to tested medicines

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fexofenadine right; placebo left	Fexofenadine	Split face double blind
Fexofenadine right; placebo left	Placebo	Split face double blind
Fexofenadine left; placebo right	Placebo	Topical treatment active versus placebo. Double blind randomized placebo controlled split face intrasubject comparison.
Fexofenadine left; placebo right	Fexofenadine	Topical treatment active versus placebo. Double blind randomized placebo controlled split face intrasubject comparison.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention	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.

Trial Locations

Locations (1)

TKL Research; 🇺🇸 Paramus, New Jersey, United States