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| Name | Class |
|---|---|
| TKL Research, Inc. | INDUSTRY |
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This study examines topical treatment of under eye circles and swelling.
This study examines topical treatment of under eyes dark circles and under eye swelling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fexofenadine left; placebo right | Experimental | Topical treatment active versus placebo. Double blind randomized placebo controlled split face intrasubject comparison. |
|
| Fexofenadine right; placebo left | Experimental | Split face double blind |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fexofenadine | Drug | Fexofenadine 1% |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, weekly, and end of study +7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward M Lane, MD | The Connecticut Sinus Center, PC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL Research | Paramus | New Jersey | 07652 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Fexofenadine Left Side; Placebo Right Side | Subjects were randomized as to side of face treated with test article versus placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adult with evidence of dark peri-orbital areas
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| ID | Title | Description |
|---|---|---|
| BG000 | Fexofenadine Right Side; Placebo Left Side | Topical treatment active versus placebo. Double blind randomized placebo controlled split face intrasubject comparison. Placebo, fexofenadine |
| BG001 | Fexofenadine Left Side; Placebo Right Side |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Thirty participants in total; 15 had fexofenadine left and placebo right; 15 had fexofenadine right and placebo left. | Posted | Number | participants | Baseline, weekly, and end of study +7 days |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Split Face Intrasubject Comparison | Topical treatment active versus placebo Double blind randomized placebo controlled split face intrasubject comparison. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward M. Lane | ConnecticutSC | 2033720009 | EMLMD@msn.com |
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| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C093230 | fexofenadine |
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| Placebo | Drug | Placebo |
|
|
Topical treatment active versus placebo. Double blind randomized placebo controlled split face intrasubject comparison. Fexofenadine, placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG000 | Fexofenadine | All participants that received fexofenadine |
| OG001 | Placebo | All participants that received placebo |
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| 0 |
| 30 |
| 0 |
| 30 |
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