Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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


Condition Intervention Phase
Edema
Drug: Fexofenadine
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by The Connecticut Sinus Center, PC:

Primary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fexofenadine left; placebo right

Topical treatment active versus placebo.

Double blind randomized placebo controlled split face intrasubject comparison.

Drug: Fexofenadine
Fexofenadine 1%
Other Name: Topical fexofenadine
Drug: Placebo
Placebo
Other Name: Topical placebo
Experimental: Fexofenadine right; placebo left
Split face double blind
Drug: Fexofenadine
Fexofenadine 1%
Other Name: Topical fexofenadine
Drug: Placebo
Placebo
Other Name: Topical placebo

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Under eye dark circles and swelling

Exclusion Criteria:

  • Under age 18
  • Allergy to tested medicines
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172522

Locations
United States, New Jersey
TKL Research
Paramus, New Jersey, United States, 07652
Sponsors and Collaborators
The Connecticut Sinus Center, PC
TKL Research, Inc.
Investigators
Study Director: Edward M Lane, MD The Connecticut Sinus Center, PC
  More Information

No publications provided

Responsible Party: The Connecticut Sinus Center, PC
ClinicalTrials.gov Identifier: NCT01172522     History of Changes
Other Study ID Numbers: CS910510
Study First Received: July 28, 2010
Results First Received: February 3, 2014
Last Updated: February 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by The Connecticut Sinus Center, PC:
Under eye dark circles
Under eye puffiness

Additional relevant MeSH terms:
Fexofenadine
Terfenadine
Anti-Allergic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015