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
1 other identifier
interventional
30
1 country
1
Brief Summary
This study examines topical treatment of under eye circles and swelling.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2010
CompletedFirst Posted
Study publicly available on registry
July 29, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
February 19, 2015
CompletedFebruary 19, 2015
February 1, 2015
3 months
July 28, 2010
February 3, 2014
February 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention
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
Study Arms (2)
Fexofenadine left; placebo right
EXPERIMENTALTopical treatment active versus placebo. Double blind randomized placebo controlled split face intrasubject comparison.
Fexofenadine right; placebo left
EXPERIMENTALSplit face double blind
Interventions
Fexofenadine 1%
Placebo
Eligibility Criteria
You may qualify if:
- Under eye dark circles and swelling
You may not qualify if:
- Under age 18
- Allergy to tested medicines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Connecticut Sinus Center, PClead
- TKL Research, Inc.collaborator
Study Sites (1)
TKL Research
Paramus, New Jersey, 07652, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Edward M. Lane
- Organization
- ConnecticutSC
Study Officials
- STUDY DIRECTOR
Edward M Lane, MD
The Connecticut Sinus Center, PC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2010
First Posted
July 29, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2010
Study Completion
January 1, 2011
Last Updated
February 19, 2015
Results First Posted
February 19, 2015
Record last verified: 2015-02