Acne VulgarisPhase 4NCT06425900
A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients
A Phase 4 study testing Winlevi (Clascoterone) cream 1% in people with Acne Vulgaris, run by Sun Pharmaceutical Industries Limited at 1 site in United States.
Trial summary
to compare facial sebaceous gland morphology after 3 months of clascoterone cream 1% treatment and to compare facial sebum constituents at baseline to facial sebum constituents after 3 months of clascoterone cream 1% treatment Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Winlevi (Clascoterone) cream 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female or male subjects age 18-35 years.
- Subjects of all Fitzpatrick skin types.
- Subjects with moderate facial acne and prominent pores indicating sebaceous gland activity.
- Subjects with oily facial skin.
- Subjects who agree to use only the study product and nothing else to the face.
- Subject must possess no scars or tattoos or other confounding dermatologic conditions on the face in the preauricular biopsy sites on the left and right face.
Show all 11Show fewer
- Subjects agree not to introduce any new skin care products during the study.
- No known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Subjects have signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects."
- 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.
Who cannot join
- Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics.
- Subjects who are not willing to use the assigned study product to their face as instructed.
- Subjects who have used any topical prescription products on the face for 4 weeks prior to study entry.
- Subjects who have used any OTC products on the face for 2 weeks.
- Subjects with clinically significant unstable medical disorders.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
- 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 currently participating in any other clinical trial.
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: Histologic and Liquid Chromatography Mass Spectrometry (LCMS) Evaluation of the Sebaceous Gland Changes Induced by Clascoterone Cream 1%
to compare facial sebaceous gland morphology after 3 months of clascoterone cream 1% treatment and to compare facial sebum constituents at baseline to facial sebum constituents after 3 months of clascoterone cream 1% treatment
- Conditions
- Acne Vulgaris
- Being tested
- Winlevi (Clascoterone) cream 1%
- 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) cream 1%Drug
Dosed twice daily (BID)
| Study group | Role | What they receive |
|---|---|---|
| Winlevi (Clascoterone ) cream 1% | Experimental | Not described Receives: Drug: Winlevi (Clascoterone) cream 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the histologic demonstration of reduced facial sebaceous gland size when comparing baseline to 3 months of clascoterone cream 1 % treatment.
Measured: Week 12
Secondary outcomes (1)
The secondary efficacy endpoint is the changes in sebum composition when comparing baseline to 3 months of clascoterone cream 1 % treatment.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Jul 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 10 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
- NCT06425900
- Sponsor's protocol ID
- DCS-115-22
- Status last verified
- Jan 2026
- First submitted
- 10 May 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histologic and Liquid Chromatography Mass Spectrometry (LCMS) Evaluation of the Sebaceous Gland Changes Induced by Clascoterone Cream 1%
- ClinicalTrials.gov ID
- NCT06425900
- Acronym / sponsor ID
- DCS-115-22
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to compare facial sebaceous gland morphology after 3 months of clascoterone cream 1% treatment and to compare facial sebum constituents at baseline to facial sebum constituents after 3 months of clascoterone cream 1% treatment
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 ) cream 1% | Experimental | Drug: Winlevi (Clascoterone) cream 1% |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Female or male subjects age 18-35 years.
- Subjects of all Fitzpatrick skin types.
- Subjects with moderate facial acne and prominent pores indicating sebaceous gland activity.
- Subjects with oily facial skin.
- Subjects who agree to use only the study product and nothing else to the face.
Key exclusion criteria (8 listed)
- Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics.
- Subjects who are not willing to use the assigned study product to their face as instructed.
- Subjects who have used any topical prescription products on the face for 4 weeks prior to study entry.
- Subjects who have used any OTC products on the face for 2 weeks.
- Subjects with clinically significant unstable medical disorders.
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) cream 1%Dosed twice daily (BID) | Drug | Winlevi (Clascoterone ) cream 1% |
Primary outcome
The primary efficacy endpoint is the histologic demonstration of reduced facial sebaceous gland size when comparing baseline to 3 months of clascoterone cream 1 % treatment.
Time frame: Week 12
1 secondary outcome
The secondary efficacy endpoint is the changes in sebum composition when comparing baseline to 3 months of clascoterone cream 1 % treatment.
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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) cream 1% 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 11 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 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?
This study is still under way. Results are not available in the source record yet.
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 histologic demonstration of reduced facial sebaceous gland size when comparing baseline to 3 months of clascoterone cream 1 % treatment. (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.