Topical Treatment of Under Eye Dark Circles and Swelling

• 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: The Connecticut Sinus Center, PC
• Collaborator: TKL Research, Inc.
• Information provided by (Responsible Party): The Connecticut Sinus Center, PC

Tracking Information

• First Submitted Date: July 28, 2010
• First Posted Date: July 29, 2010
• Results First Submitted Date: February 3, 2014
• Results First Posted Date: February 19, 2015
• Last Update Posted Date: February 19, 2015
• Study Start Date: September 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 16, 2015)

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.

Original Primary Outcome Measures (submitted: July 28, 2010)

Change in puffiness and dark circles relative to baseline [ Time Frame: Baseline, 29 days ]

Efficacy of actives versus placebo

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Topical Treatment of Under Eye Dark Circles and Swelling
• 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
• Brief Summary: This study examines topical treatment of under eye circles and swelling.
• Detailed Description: This study examines topical treatment of under eyes dark circles and under eye swelling.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Edema

Intervention

• Drug: Fexofenadine
  Fexofenadine 1%
  Other Name: Topical fexofenadine
• Drug: Placebo
  Placebo
  Other Name: Topical placebo

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 28, 2010): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2011
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Under eye dark circles and swelling

Exclusion Criteria:

• Under age 18
• Allergy to tested medicines

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01172522
• Other Study ID Numbers: CS910510
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: The Connecticut Sinus Center, PC
• Original Responsible Party: Edward M. Lane, MD, The Connecticut Sinus Center PC
• Current Study Sponsor: The Connecticut Sinus Center, PC
• Original Study Sponsor: Same as current
• Collaborators: TKL Research, Inc.

Investigators

• Study Director: Edward M Lane, MD; The Connecticut Sinus Center, PC

• PRS Account: The Connecticut Sinus Center, PC
• Verification Date: February 2015