Topical Treatment of Under Eye Dark Circles and Swelling

• Sponsor: The Connecticut Sinus Center, PC (Other)
• Overall Status: Completed
• CT.gov ID: NCT01172522
• Collaborator: TKL Research, Inc. (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 7.5

Study Details

Study Description

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

• Study Type: Interventional
• 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: Sep 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Under eye dark circles and swelling

Exclusion Criteria:

• Under age 18

• Allergy to tested medicines

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Connecticut Sinus Center, PC
• ClinicalTrials.gov Identifier: NCT01172522
• Other Study ID Numbers: CS910510
• First Posted: Jul 29, 2010
• Last Update Posted: Feb 19, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by The Connecticut Sinus Center, PC: Under eye dark circles; Under eye puffiness
• Additional relevant MeSH terms: Fexofenadine; Terfenadine

Study Results

Participant Flow

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 Participants	15	15	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30 (15)	30 (15)	30 (15)
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 100%	15 100%	30 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	12 80%	12 80%	24 80%
Male	3 20%	3 20%	6 20%
Region of Enrollment (participants) [Number]
United States	15 100%	15 100%	30 100%

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
Measure Participants	30	30
Number [participants]	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fexofenadine, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=1
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Other
	Estimated Value	0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	P values above 0.05 is considered statistically insignificant in this study.

Adverse Events

Time Frame	4 weeks
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Split Face Intrasubject Comparison
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Split Face Intrasubject Comparison
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.