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

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Edema
• Interventions: Drug: Fexofenadine; Drug: Placebo
• Enrollment: 30

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Fexofenadine Right Side; Placebo Left Side	Fexofenadine Left Side; Placebo Right Side
Arm/Group Description	Topical treatment active versus placebo. Double blind randomized placebo controlled split face intrasubject comparison. Participants were randomized to side of face with active drug versus side of face with control, but with each treatment going on concurrently.	Subjects were randomized as to side of face treated with test article versus placebo
Period Title: Overall Study
Started	15	15
Completed	15	15
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Fexofenadine Right Side; Placebo Left Side	Fexofenadine Left Side; Placebo Right Side	Total
Arm/Group Description		Topical treatment active versus placebo. Double blind randomized placebo controlled split face intrasubject comparison. Placebo, fexofenadine	Topical treatment active versus placebo. Double blind randomized placebo controlled split face intrasubject comparison. Fexofenadine, placebo	Total of all reporting groups
Overall Number of Baseline Participants		15	15	30
Baseline Analysis Population Description		Adult with evidence of dark peri-orbital areas
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	15 participants	15 participants	30 participants
		30 (15)	30 (15)	30 (15)
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	15 participants	30 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	15 100.0%	15 100.0%	30 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	15 participants	30 participants
	Female	12 80.0%	12 80.0%	24 80.0%
	Male	3 20.0%	3 20.0%	6 20.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	15 participants	15 participants	30 participants
		15	15	30

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention
Description	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.
Time Frame	Baseline, weekly, and end of study +7 days

Outcome Measure Data

Analysis Population Description

Thirty participants in total; 15 had fexofenadine left and placebo right; 15 had fexofenadine right and placebo left.

Arm/Group Title	Fexofenadine	Placebo
Arm/Group Description:	All participants that received fexofenadine	All participants that received placebo
Overall Number of Participants Analyzed	30	30
Measure Type: Number; Unit of Measure: participants
	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fexofenadine, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	=1
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Other
	Estimated Value	0
	Estimation Comments	P values above 0.05 is considered statistically insignificant in this study.

Adverse Events

Time Frame	4 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Split Face Intrasubject Comparison
Arm/Group Description	Topical treatment active versus placebo Double blind randomized placebo controlled split face intrasubject comparison.
All-Cause Mortality
	Split Face Intrasubject Comparison
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Split Face Intrasubject Comparison
	Affected / at Risk (%)
Total	0/30 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Split Face Intrasubject Comparison
	Affected / at Risk (%)
Total	0/30 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Edward M. Lane
• Organization: ConnecticutSC
• Phone: 2033720009
• EMail: EMLMD@msn.com

• Responsible Party: The Connecticut Sinus Center, PC
• ClinicalTrials.gov Identifier: NCT01172522
• Other Study ID Numbers: CS910510
• First Submitted: July 28, 2010
• First Posted: July 29, 2010
• Results First Submitted: February 3, 2014
• Results First Posted: February 19, 2015
• Last Update Posted: February 19, 2015