Trial Outcomes & Findings for Topical Treatment of Under Eye Dark Circles and Swelling (NCT NCT01172522)
NCT ID: NCT01172522
Last Updated: 2015-02-19
Results Overview
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.
COMPLETED
PHASE2
30 participants
Baseline, weekly, and end of study +7 days
2015-02-19
Participant Flow
Participant milestones
| Measure |
Fexofenadine Right Side; Placebo Left Side
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.
|
Fexofenadine Left Side; Placebo Right Side
Subjects were randomized as to side of face treated with test article versus placebo
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Treatment of Under Eye Dark Circles and Swelling
Baseline characteristics by cohort
| Measure |
Fexofenadine Right Side; Placebo Left Side
n=15 Participants
Topical treatment active versus placebo.
Double blind randomized placebo controlled split face intrasubject comparison.
Placebo, fexofenadine
|
Fexofenadine Left Side; Placebo Right Side
n=15 Participants
Topical treatment active versus placebo.
Double blind randomized placebo controlled split face intrasubject comparison.
Fexofenadine, placebo
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 15 • n=99 Participants
|
30 years
STANDARD_DEVIATION 15 • n=107 Participants
|
30 years
STANDARD_DEVIATION 15 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, weekly, and end of study +7 daysPopulation: Thirty participants in total; 15 had fexofenadine left and placebo right; 15 had fexofenadine right and placebo left.
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.
Outcome measures
| Measure |
Fexofenadine
n=30 Participants
All participants that received fexofenadine
|
Placebo
n=30 Participants
All participants that received placebo
|
|---|---|---|
|
Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention
|
0 participants
|
0 participants
|
Adverse Events
Split Face Intrasubject Comparison
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place