Acne VulgarisPhase 4NCT06415279
A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients
A Phase 4 study testing Winlevi (clascoterone) 1% cream in people with Acne Vulgaris, run by Sun Pharmaceutical Industries Limited at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Winlevi (clascoterone) 1% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2024to 12 Feb 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females 12+ years of age.
- Subjects with mild to moderate acne.
- Subjects must possess 10-100 total non-inflammatory lesions (open comedones and closed comedones), 10-50 total inflammatory lesions, no cysts, and up to 2 nodules (if deemed appropriate by the PI) on the face.
- Subjects with all Fitzpatrick skin types I-VI.
- Subjects who agree to use only the study products for acne treatment. No other medicated cleansers or moisturizers or acne treatments of any kind are allowed.
- Subjects agree not to introduce any new colored cosmetics or skin care products while participating in the study (lipsticks, eye shadows, facial foundations, blush, powder, cleansers, moisturizers).
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- Subjects agree to arrive at all visits with a clean face, having washed his/her face and removed all facial and eye makeup products within 2 hours to 4 hours prior to the visit and is not to use/apply any topical facial product(s) until the visit is completed.
- No known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier methods (e.g., condom and spermicide) and abstinence.
- Subjects are dependable and able to follow directions and willing to comply with the schedule of visits.
- Subjects in generally good physical and mental health.
- Able to read, write, speak, and understand English
- Individual (and/or his/her legally acceptable representative, as applicable) has signed the Consent for Photograph Release and ICD (and/or Assent Document, as applicable) including Health Insurance Portability and Accountability Act (HIPAA) disclosure.
- Subject must avoid sun exposure, or use sunscreen if sun exposure is unavoidable.
- Subject must avoid professional or facial spa procedures during the study.
Who cannot join
- 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®)
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- 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:
- Light therapy
- OTC topical medications/products (including antiacne or antibacterial agents, topical anti-inflammatories, topical retinoids, etc.). Sunscreens (SPF) are acceptable.
- 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:
- Immunosuppressive drugs and steroidal and/or non-steroidal anti-inflammatory drugs within 3 months before Visit 1 and during the study.
- Regular use of antihistamines within 1 month before Visit 1 and during the study.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Consulting Services, PLLC
High Point, North Carolina, 27262
About this study
Official title: Clinical Evaluation of the Sebum Reduction Induced by Clascoterone Cream 1%
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.
- Conditions
- Acne Vulgaris
- Being tested
- Winlevi (clascoterone) 1% cream
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Winlevi (clascoterone) 1% creamDrug
Twice daily (BID) dosing
| Study group | Role | What they receive |
|---|---|---|
| Winlevi (clascoterone) 1% cream | Experimental | Not described Receives: Drug: Winlevi (clascoterone) 1% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Weeks 16
Secondary outcomes (1)
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.
Measured: Baseline, Week 12, and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start14 Feb 2024
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415279
- Sponsor's protocol ID
- DCS-67-22
- Status last verified
- May 2026
- First submitted
- 10 May 2024
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40682762
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Sebum Reduction Induced by Clascoterone Cream 1%
- ClinicalTrials.gov ID
- NCT06415279
- Acronym / sponsor ID
- DCS-67-22
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Posted 15 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Winlevi (clascoterone) 1% cream | Experimental | Drug: Winlevi (clascoterone) 1% cream |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Males and females 12+ years of age.
- Subjects with mild to moderate acne.
- Subjects must possess 10-100 total non-inflammatory lesions (open comedones and closed comedones), 10-50 total inflammatory lesions, no cysts, and up to 2 nodules (if deemed appropriate by the PI) on the face.
- Subjects with all Fitzpatrick skin types I-VI.
- Subjects who agree to use only the study products for acne treatment. No other medicated cleansers or moisturizers or acne treatments of any kind are allowed.
Key exclusion criteria (26 listed)
- 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):
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Winlevi (clascoterone) 1% creamTwice daily (BID) dosing | Drug | Winlevi (clascoterone) 1% cream |
Primary outcome
The Primary Efficacy Endpoint is the Change in Causal Sebum Measurements From the Forehead Obtained With a Sebumeter During the Study.
Time frame: Weeks 16
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%.
1 secondary outcome
The Secondary Efficacy Endpoint is the Changes in the Facial Microbiome Induced by 12, and 52 Weeks of Clascoterone 1% Cream Application.
Time frame: Baseline, Week 12, and Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40682762Draelos 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Winlevi (clascoterone) 1% cream in people with Acne Vulgaris, run by Sun Pharmaceutical Industries Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Efficacy Endpoint is the Change in Causal Sebum Measurements From the Forehead Obtained With a Sebumeter During the Study. (time frame: Weeks 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06415279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.