Topical Treatment of Under Eye Dark Circles and Swelling

Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172522
• Other study ID #: CS910510
• Status: Completed
• Phase: Phase 2
• First received: July 28, 2010
• Last updated: February 16, 2015
• Start date: September 2010
• Est. completion date: January 2011

Study information

• Verified date: February 2015
• Source: The Connecticut Sinus Center, PC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Under eye dark circles and swelling

Exclusion Criteria:

• Under age 18

• Allergy to tested medicines

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema

Intervention

Drug:
• Fexofenadine
Fexofenadine 1%
• Placebo
Placebo

Locations

Country	Name	City	State
United States	TKL Research	Paramus	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
The Connecticut Sinus Center, PC	TKL Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention	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.	Baseline, weekly, and end of study +7 days	No