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Acne medications are a common source of facial dryness resulting in skin barrier damage and poor patient compliance. Retinoids and benzoyl peroxide are some of the most frequently prescribed and effective acne medications, however, dryness is an unwanted side effect. A new acne medication, 1% clascoterone, has been placed in a novel vehicle for excellent drug delivery in combination with excellent barrier properties. The barrier properties of 1% clascoterone have never been demonstrated. This study is aimed at better understanding the positive barrier effects of 1% clascoterone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Winlevi (clascoterone) 1% treated | Experimental | Splitface design- Subjects applied Winlevi (clascoterone) cream 1%, twice daily to the randomized half face following cleansing, every morning and evening. |
|
| Splitface design- No study product | No Intervention | Splitface design-no study product was applied to the untreated side of the face |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Winlevi (clascoterone) 1% cream | Drug | Splitface design- Subjects applied Winlevi (clascoterone) cream 1%, twice daily to the randomized half face following cleansing, every morning and evening. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Endpoint is the Change in Corneometry Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment. | The Corneometer measures skin hydration with a range of 0- 1000 MicroSiemens, where 0 is lowest and 1000 is highest hydration | Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TEWL Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment | The instrument measures trans epidermal water loss (abbreviated as TEWL) which ranges from minimum 0 (no trans epidermal water loss) to maximum 100 (high trans epidermal water loss) | Week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Consulting Services, PLLC | High Point | North Carolina | 27262 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Winlevi (Clascoterone) 1% Treated | This study involved 50 subjects. Splitface design- Subjects applied Winlevi(clascoterone) cream 1%, twice daily to the randomized half face following cleansing, everymorning and evening. No study product was applied to the untreated side of the face |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Winlevi (Clascoterone) 1% Treated | Winlevi (clascoterone) 1% cream: Split face. Blinded study treatment product to be applied to the randomized half face |
| 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, Categorical | Count of Participants |
| 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 | The Primary Endpoint is the Change in Corneometry Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment. | The Corneometer measures skin hydration with a range of 0- 1000 MicroSiemens, where 0 is lowest and 1000 is highest hydration | Posted | Mean | Standard Deviation | microSiemens (μS) | Week 2 |
|
2 Weeks
There was only one patient that report Covid 19 during the study, this patient applied winlevi to one side of the face and the other side was left untreated.
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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 | Winlevi (Clascoterone) 1% Treated | Winlevi (clascoterone) 1% cream: Split face. Blinded study treatment product to be applied to the randomized half face |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid 19 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head-Regulatory Affairs | Sun Pharmaceutical Industries Limited | 2266455645 | 5689 | Clinical.Trial@sunpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2023 | Dec 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C496269 | Clascoterone |
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Patients were randomized to apply treatment (winlevi 1%) to one side of the face and the other side of the face remained untreated
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The Outcomes Assessor/Investigator was blinded to which side of the face received the treatment
| Participants |
| No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Secondary | Change in TEWL Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment | The instrument measures trans epidermal water loss (abbreviated as TEWL) which ranges from minimum 0 (no trans epidermal water loss) to maximum 100 (high trans epidermal water loss) | Posted | Mean | Standard Deviation | g/h/m² | Week 2 |
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| 0 |
| 50 |
| 0 |
| 50 |
| 1 |
| 50 |
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