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OpenTrials
Completed

NCT Number: NCT01172522

Topical Treatment of Under Eye Dark Circles and Swelling

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

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Key information

Conditions

Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

TKL Research

Paramus, New Jersey, 07652, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Under eye dark circles and swelling

Exclusion criteria

  • Under age 18
  • Allergy to tested medicines

Treatment and study plan

fexofenadine

Drug

Fexofenadine 1%

Other names: Topical fexofenadine

Placebo

Drug

Placebo

Other names: Topical placebo

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Connecticut Sinus Center, PC

Other

Collaborators

  • TKL Research, Inc.

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jul 29, 2010
Registry last updated
Feb 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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