Acne VulgarisPhase 4NCT06415305
A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne
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
Acne vulgaris is the most common skin disease in patients with skin of color and second most common in Caucasian population. The global prevalence is thought to be as high as 60-80% in individuals 12-25 years of age. However, it is not limited to only teenagers but also to adults, especially adult females. 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 30 Jan 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
- Outpatient, male or female subjects of any race (Fitzpatrick skin types IV, V, VI), and at least 12 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study:
- A female is considered of childbearing potential unless she is:
- postmenopausal for at least 12 months prior to study drug administration;
- without a uterus and/or both ovaries; or
- has been surgically sterile for at least 6 months prior to study drug administration.
- Reliable methods of contraception are:
Show all 10Show fewer
- hormonal methods or intrauterine device in use > 90 days prior to study drug administration;
- barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
- vasectomized partner (vasectomy must be performed 3 months prior to first study drug administration or in the alternative a zero sperm count will suffice)
- [Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.] ii. Facial acne IGA score of 3 or 4. iii. Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.
Who cannot join
- Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- Allergy or sensitivity to any component of the test medications (Section 5.2).
- Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).
- Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study.
- Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris vi. Evidence of recent alcohol or drug abuse. vii. History of poor cooperation, non-compliance with medical treatment, or unreliability.
- Exposure to an investigational drug study within 30 days of the Baseline Visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Winlevi in Skin of Color Patients With Acne
Acne vulgaris is the most common skin disease in patients with skin of color and second most common in Caucasian population. The global prevalence is thought to be as high as 60-80% in individuals 12-25 years of age. However, it is not limited to only teenagers but also to adults, especially adult females. The pathogenesis of acne is multifactorial. Genetics may also play a role. The treatment pathway should be directed to different pathogenic factors including, excessive sebum production, hyper keratinization, P. acnes, and inflammation.
Data is limited for skin of color patients in Phase III registration trials. Data is limited because there are few studies that focus on patients with skin of color. Therefore, a unique study dedicated to patients with skin of color in a real-world setting will be welcome to add further evidence to phase III data.
- 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
Dosed twice daily (BID)
| 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 Endpoint of This Study is the Percent of Patients Who Achieved Clear (0) or Almost Clear (1) on IGA Scale at Week 16
Measured: Week 16
Secondary outcomes (9)
Percent of Total Lesion Reduction at Week 16 Compared to Baseline
The data reports the average percent reduction in total lesion count form Baseline to Week 16
Measured: Week 16
Percent of Inflammatory Lesion Reduction at Week 16 Compared to Baseline
The data reported represents the average percent reduction in inflammatory lesion count form Baseline to Week 16
Measured: Week 16
Percent of Non-inflammatory Lesion Reduction at Week 16 Compared to Baseline
The average percent reduction in non-inflammatory lesion count form Baseline to Week 16
Measured: Week 16
Tolerability Measures of Erythema Based on 5-point Severity Scale
The score in the scale ranges from 0-4. Lower score represents absence of erythema and higher score represents severe condition.
The information presented represents the "Percentage of participant" with "Absent or Trace" erythema at Week 52
Measured: Week 52
Tolerability Measures of Dryness Based on 5-point Severity Scale
The score in the scale ranges from 0-4. Lower score represents absence of dryness and higher score represents severe condition.
The information presented represents the "Percentage of participant" with "Absent or Trace" Dryness at Week 52
Measured: Week 52
Tolerability Measures of Peeling Based on 5-point Severity Scale
The score in the scale ranges from 0-4. Score 0 represents absence of peeling and Score 4 represents 'Extensive peeling'.
The information presented represents the "Percentage of participant" with "Absent or Trace" peeling at week 52
Measured: Week 52
Assessment of Skin Oiliness Based on 5-point Severity Scale
The score in the scale ranges from 0-4. Score 0 represents absence of Oiliness and Score 4 represents severe condition.
The information presented represents the "Percentage of participant" with "Absent or Trace" oiliness at week 52
Measured: Week 52
Tolerability Measures of Pruritus Based on 6-point Severity Scale
The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition.
The information presented represents the "Percentage of participant" with "Absent or Trace" pruritus at week 52
Measured: Week 52
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale
The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition.
The information presented represents the "Percentage of participant" with "Absent or Trace" burning/stinging at week 52
Measured: 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 start1 Sep 2023
- Primary completion17 Apr 2024
- Study completion30 Jan 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.
- 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
- NCT06415305
- Sponsor's protocol ID
- WINSCO - 2023
- Status last verified
- Apr 2025
- First submitted
- 10 May 2024
- Last updated
- 16 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Winlevi in Skin of Color Patients With Acne
- ClinicalTrials.gov ID
- NCT06415305
- Acronym / sponsor ID
- WINSCO - 2023
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Posted 7 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acne vulgaris is the most common skin disease in patients with skin of color and second most common in Caucasian population. The global prevalence is thought to be as high as 60-80% in individuals 12-25 years of age. However, it is not limited to only teenagers but also to adults, especially adult females. The pathogenesis of acne is multifactorial. Genetics may also play a role. The treatment pathway should be directed to different pathogenic factors including, excessive sebum production, hyper keratinization, P. acnes, and inflammation.
Data is limited for skin of color patients in Phase III registration trials. Data is limited because there are few studies that focus on patients with skin of color. Therefore, a unique study dedicated to patients with skin of color in a real-world setting will be welcome to add further evidence to phase III data.
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 (10 listed)
- Outpatient, male or female subjects of any race (Fitzpatrick skin types IV, V, VI), and at least 12 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study:
- postmenopausal for at least 12 months prior to study drug administration;
- without a uterus and/or both ovaries; or
- has been surgically sterile for at least 6 months prior to study drug administration.
- hormonal methods or intrauterine device in use > 90 days prior to study drug administration;
Key exclusion criteria (6 listed)
- Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- Allergy or sensitivity to any component of the test medications (Section 5.2).
- Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).
- Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study.
- Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris vi. Evidence of recent alcohol or drug abuse. vii. History of poor cooperation, non-compliance with medical treatment, or unreliability.
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% creamDosed twice daily (BID) | Drug | Winlevi (clascoterone) 1% cream |
Primary outcome
The Primary Endpoint of This Study is the Percent of Patients Who Achieved Clear (0) or Almost Clear (1) on IGA Scale at Week 16
Time frame: Week 16
9 secondary outcomes
Percent of Total Lesion Reduction at Week 16 Compared to Baseline
Time frame: Week 16
Percent of Inflammatory Lesion Reduction at Week 16 Compared to Baseline
Time frame: Week 16
Percent of Non-inflammatory Lesion Reduction at Week 16 Compared to Baseline
Time frame: Week 16
Tolerability Measures of Erythema Based on 5-point Severity Scale
Time frame: Week 52
Tolerability Measures of Dryness Based on 5-point Severity Scale
Time frame: Week 52
Tolerability Measures of Peeling Based on 5-point Severity Scale
Time frame: Week 52
Assessment of Skin Oiliness Based on 5-point Severity Scale
Time frame: Week 52
Tolerability Measures of Pruritus Based on 6-point Severity Scale
Time frame: Week 52
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 10 inclusion and 6 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 16 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?
Yes. Results are posted in the registry (first posted 7 May 2025). 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 Endpoint of This Study is the Percent of Patients Who Achieved Clear (0) or Almost Clear (1) on IGA Scale at Week 16 (time frame: Week 16). 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 16 Jan 2026.