Topical Treatment of Under Eye Dark Circles and Swelling

February 16, 2015 updated by: The Connecticut Sinus Center, PC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • TKL Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Under eye dark circles and swelling

Exclusion Criteria:

  • Under age 18
  • Allergy to tested medicines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fexofenadine left; placebo right

Topical treatment active versus placebo.

Double blind randomized placebo controlled split face intrasubject comparison.
Drug: Placebo
Placebo
Other Names:
  • Topical placebo
Drug: Fexofenadine
Fexofenadine 1%
Other Names:
  • Topical fexofenadine
EXPERIMENTAL: Fexofenadine right; placebo left
Split face double blind
Drug: Placebo
Placebo
Other Names:
  • Topical placebo
Drug: Fexofenadine
Fexofenadine 1%
Other Names:
  • Topical fexofenadine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, weekly, and end of study +7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Connecticut Sinus Center, PC

Collaborators

TKL Research, Inc.

Investigators

  • Study Director: Edward M Lane, MD, The Connecticut Sinus Center, PC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

July 28, 2010

First Submitted That Met QC Criteria

July 28, 2010

First Posted (ESTIMATE)

July 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2015

Last Update Submitted That Met QC Criteria

February 16, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS910510

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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