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The etiology of acne is heavily dependent on the production of sebum by the sebaceous glands that results in the growth of the bacteria c. acnes. If no sebum is present, there is no nutritional source for the c. acnes, the bacteria die, and acne resolves. An FDA approved acne medication consisting of clascoterone cream 1% is believed to effectively treat acne due to a decrease in sebum production. This mechanism of action has been postulated based on efficacy observed in the phase III trials that lead to its approval. This research aims to demonstrate the effect of clascoterone cream 1% in sebum reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Winlevi (clascoterone) 1% cream | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Winlevi (clascoterone) 1% cream | Drug | Twice daily (BID) dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Efficacy Endpoint is the Change in Causal Sebum Measurements From the Forehead Obtained With a Sebumeter During the Study. | The values represents the mean change from baseline. Casual sebum level is measured using a Sebumeter by means of grease-spot photometry. In this method, the measuring head of a cassette probe briefly exposes a section of a mat tape and brings it into contact with the sebum present on the surface of the forehead. As the tape absorbs sebum, it becomes increasingly transparent; conversely, lower levels of sebum result in less transparency. After contact, the tape is inserted into the device, which determines its transparency using a photocell-based light transmission measurement. The amount of transmitted light-reported in units from 0 to 350 µg/cm²-corresponds to the level of sebum present on the skin surface. The measurement has an estimated uncertainty of ±5%. | Weeks 16 |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Efficacy Endpoint is the Changes in the Facial Microbiome Induced by 12, and 52 Weeks of Clascoterone 1% Cream Application. | Changes in the skin microbiome - specifically Cutibacterium acnes - were evaluated by swabbing each subject's forehead to obtain microbiological samples. The swab samples were treated with metapolyzyme to lyse cells, after which DNA was isolated and quantified. DNA sequencing was used to quantify Cutibacterium acnes as relative abundance, defined as the proportion of total bacterial sequencing reads attributable to C. acnes (range, 0-1). For each sample, the abundance score of C. acnes was converted to relative abundance, and descriptive statistics (mean, median, and standard deviation) were calculated across time points. Statistical significance between pairs of time points was assessed using a Wilcoxon rank-sum test, implemented within the ggpubr plotting framework. |
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Inclusion Criteria:
Exclusion Criteria:
Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, except for the study condition of acne.
Subjects who are not willing to use the assigned study product to their face as instructed.
Subjects who have acne nodules/cysts representative of severe acne.
Subjects who are currently using, planning to use during the study or has used any of the following in the specified time range (based on subject report):
1 month prior to Visit 1: Prescription (oral or topically applied on the face) antibiotics, inhaled steroids (except those prescribed for allergies), or hormones (pre- or post-menopausal hormone-replacement therapy; insulin, etc.), or other medications that could make skin more sensitive or have an effect on the skin, as determined by the PI or designee. Oral contraceptives are acceptable.
1 month prior to Visit 1: Prescription medication for acne (e.g. doxycycline, minocycline, clindamycin, sulfamethoxazole and trimethoprim [Bactrim], tetracycline, erythromycin, azithromycin, or Vibramycin®)
1 month prior to Visit 1: Topical prescription retinoids (e.g. Retin-A®, Retin-A Micro®, Renova®, Adapalene, Tazarotene, Avita®, Tazorac®, Avage®, Differin®), azelaic acid, benzoyl peroxide, dapsone, sodium sulfacetamide, Epiduo®, or other similar prescription drug on the face
6 months prior to Visit 1: Accutane or other oral retinoid
2 weeks prior to Visit 1: Any of the following on the face:
Females who are pregnant, lactating, or planning to become pregnant during the study or within 30 days of study completion. (Subject must document her response in either the source documentation or informed consent/assent forms).
Subject has a surgery and/or invasive medical procedure planned during the study.
Subject has observable suntan, scars, nevi, tattoo, excessive hair (including beard, mustache, or goatee), or other dermal conditions on the face that that could interfere with study evaluations or confound study results, as determined by the PI or designee.
Subject is taking medications that would mask an adverse event (AE) or influence the study results, including:
Subject has a history of or a concurrent health condition/situation, which in the opinion of the PI, if medically qualified, or Study Physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study.
Subject is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor.
Subjects with clinically significant unstable medical disorders.
Subjects who are unwilling or unable to comply with the requirements of the protocol.
Subjects with any known allergies or sensitivities to the study acne products.
Subjects who are currently under the care of a dermatologist for acne.
Subjects who are currently experiencing an acne flare.
Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
Subjects having started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to the study entry or who plan on starting, stopping or changing doses of HRT or hormones for birth control during the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Consulting Services, PLLC | High Point | North Carolina | 27262 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40682762 | Derived | Draelos ZD, Kyeremateng K, Squittieri N. Reduction in Facial Sebum Production Following Treatment with Clascoterone Cream 1% in Patients with Acne Vulgaris: 12-Week Interim Analysis. Dermatol Ther (Heidelb). 2025 Sep;15(9):2657-2666. doi: 10.1007/s13555-025-01495-y. Epub 2025 Jul 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Winlevi (Clascoterone) 1% Cream | Winlevi (clascoterone) 1% cream: Twice daily (BID) dosing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Winlevi (Clascoterone) 1% Cream | Winlevi (clascoterone) 1% cream: Twice daily (BID) dosing |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Efficacy Endpoint is the Change in Causal Sebum Measurements From the Forehead Obtained With a Sebumeter During the Study. | The values represents the mean change from baseline. Casual sebum level is measured using a Sebumeter by means of grease-spot photometry. In this method, the measuring head of a cassette probe briefly exposes a section of a mat tape and brings it into contact with the sebum present on the surface of the forehead. As the tape absorbs sebum, it becomes increasingly transparent; conversely, lower levels of sebum result in less transparency. After contact, the tape is inserted into the device, which determines its transparency using a photocell-based light transmission measurement. The amount of transmitted light-reported in units from 0 to 350 µg/cm²-corresponds to the level of sebum present on the skin surface. The measurement has an estimated uncertainty of ±5%. | Posted | Mean | Standard Deviation | µg/cm² | Weeks 16 |
|
52 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 | Winlevi (Clascoterone) 1% Cream | Winlevi (clascoterone) 1% cream: Twice daily (BID) dosing |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mycoplasma pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head-Regulatory Affairs | Sun Pharmaceutical Industries Limited | 0226645 | 5789 | 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 | Dec 15, 2023 | Feb 17, 2026 | 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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| Baseline, Week 12, and Week 52 |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
Winlevi (clascoterone) 1% cream: Twice daily (BID) dosing |
|
|
|
| Secondary | The Secondary Efficacy Endpoint is the Changes in the Facial Microbiome Induced by 12, and 52 Weeks of Clascoterone 1% Cream Application. | Changes in the skin microbiome - specifically Cutibacterium acnes - were evaluated by swabbing each subject's forehead to obtain microbiological samples. The swab samples were treated with metapolyzyme to lyse cells, after which DNA was isolated and quantified. DNA sequencing was used to quantify Cutibacterium acnes as relative abundance, defined as the proportion of total bacterial sequencing reads attributable to C. acnes (range, 0-1). For each sample, the abundance score of C. acnes was converted to relative abundance, and descriptive statistics (mean, median, and standard deviation) were calculated across time points. Statistical significance between pairs of time points was assessed using a Wilcoxon rank-sum test, implemented within the ggpubr plotting framework. | One subject discontinued due to withdrawal of consent. | Posted | Median | Inter-Quartile Range | Proportion relative to total | Baseline, Week 12, and Week 52 |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 1 |
| 40 |
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|
| Week 52 |
|
|
| Superiority |