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Topical Treatment of Under Eye Dark Circles and Swelling

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ClinicalTrials.gov Identifier: NCT01172522
Recruitment Status : Completed
First Posted : July 29, 2010
Results First Posted : February 19, 2015
Last Update Posted : February 19, 2015
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
The Connecticut Sinus Center, PC

Study Description
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Brief Summary:
This study examines topical treatment of under eye circles and swelling.

Condition or disease Intervention/treatment Phase
Edema Drug: Fexofenadine Drug: Placebo Phase 2

Detailed Description:
This study examines topical treatment of under eyes dark circles and under eye swelling.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172522


Locations
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United States, New Jersey
TKL Research
Paramus, New Jersey, United States, 07652
Sponsors and Collaborators
The Connecticut Sinus Center, PC
TKL Research, Inc.
Investigators
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Study Director: Edward M Lane, MD The Connecticut Sinus Center, PC
More Information
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Responsible Party: The Connecticut Sinus Center, PC
ClinicalTrials.gov Identifier: NCT01172522    
Other Study ID Numbers: CS910510
First Posted: July 29, 2010    Key Record Dates
Results First Posted: February 19, 2015
Last Update Posted: February 19, 2015
Last Verified: February 2015
Keywords provided by The Connecticut Sinus Center, PC:
Under eye dark circles
Under eye puffiness
Additional relevant MeSH terms:
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Fexofenadine
Terfenadine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
 Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs