Edema
Conditions
Keywords
Under eye dark circles, Under eye puffiness
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.
Interventions
DRUGFexofenadine
Fexofenadine 1%
DRUGPlacebo
Placebo
Sponsors
TKL Research, Inc.
The Connecticut Sinus Center, PC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Under eye dark circles and swelling
Exclusion criteria
* Under age 18 * Allergy to tested medicines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fexofenadine Right Side; Placebo Left Side Topical treatment active versus placebo.
Double blind randomized placebo controlled split face intrasubject comparison.
Placebo, fexofenadine | 15 |
| Fexofenadine Left Side; Placebo Right Side Topical treatment active versus placebo.
Double blind randomized placebo controlled split face intrasubject comparison.
Fexofenadine, placebo | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Fexofenadine Right Side; Placebo Left Side | Fexofenadine Left Side; Placebo Right Side | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Continuous | 30 years STANDARD_DEVIATION 15 | 30 years STANDARD_DEVIATION 15 | 30 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention
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
Population: Thirty participants in total; 15 had fexofenadine left and placebo right; 15 had fexofenadine right and placebo left.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fexofenadine | Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention | 0 participants |
| Placebo | Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention | 0 participants |
p-value: =1Chi-squared