Topical Treatment of Under Eye Dark Circles and Swelling

This study has been completed.
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
The Connecticut Sinus Center, PC
ClinicalTrials.gov Identifier:
NCT01172522
First received: July 28, 2010
Last updated: February 16, 2015
Last verified: February 2015

July 28, 2010
February 16, 2015
September 2010
December 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Change in puffiness and dark circles relative to baseline [ Time Frame: Baseline, 29 days ] [ Designated as safety issue: No ]
Efficacy of actives versus placebo
Complete list of historical versions of study NCT01172522 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Topical Treatment of Under Eye Dark Circles and Swelling
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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Edema
  • Drug: Fexofenadine
    Fexofenadine 1%
    Other Name: Topical fexofenadine
  • Drug: Placebo
    Placebo
    Other Name: Topical placebo
  • Experimental: Fexofenadine left; placebo right

    Topical treatment active versus placebo.

    Double blind randomized placebo controlled split face intrasubject comparison.

    Interventions:
    • Drug: Fexofenadine
    • Drug: Placebo
  • Experimental: Fexofenadine right; placebo left
    Split face double blind
    Interventions:
    • Drug: Fexofenadine
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Under eye dark circles and swelling

Exclusion Criteria:

  • Under age 18
  • Allergy to tested medicines
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01172522
CS910510
Yes
The Connecticut Sinus Center, PC
The Connecticut Sinus Center, PC
TKL Research, Inc.
Study Director: Edward M Lane, MD The Connecticut Sinus Center, PC
The Connecticut Sinus Center, PC
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP