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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: July 29, 2013
Last verified: July 2013

July 28, 2010
July 29, 2013
September 2010
December 2010   (final data collection date for primary outcome measure)
Change in puffiness and dark circles relative to baseline [ Time Frame: Baseline, 29 days ] [ Designated as safety issue: No ]
Efficacy of actives versus placebo
Same as current
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 eye circles and swelling.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Edema
  • Drug: Fexofenadine
    Fexofenadine 1%
    Other Name: Fexofenadine, Ibuprofen
  • Drug: Placebo
    Placebo
  • Placebo Comparator: Placebo

    Topical treatment active versus placebo.

    Double blind randomized placebo controlled split face intrasubject comparison.

    Intervention: Drug: Placebo
  • Experimental: Fexofenadine

    Topical treatment active versus placebo.

    Double blind randomized placebo controlled split face intrasubject comparison.

    Intervention: Drug: Fexofenadine
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
July 2013

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