Acne VulgarisPhase 3NCT06403501
Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris
A Phase 3 study testing Clascoterone in people with Acne Vulgaris, run by Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to determine the safety and efficacy of clascoterone cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris. 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?
- Clascoterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 692 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2024to Oct 2026
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with facial acne vulgaris (which includes the nose) from moderate to severe, has an Investigator's Global Assessment (IGA) score of 3 or 4; with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones);
- Male or female, 12 years of age or older;
- Subjects aged 18 years or older are required to provide informed consent and sign the written informed consent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of consent signing.
Who cannot join
- Subject has greater than two (2) facial nodules;
- Subject has any skin pathology or condition that could interfere with the investigator's clinical evaluation of the investigational drug;
- Subject has used topical and systemic anti-acne medications or therapies;
- Subject has received hormonal therapy for acne treatment;
- Subject has used a skincare product with acne removal effect;
- Subject has other serious underlying diseases such as mental illness or malignant tumors;
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- Subject has any of the clinically significant laboratory test indicators at screening;
- Subject has known hypersensitivity or previous allergic reaction to multiple drugs, or any of the active or inactive components of the test articles;
- Subject engaged in drug abuse or excessive alcohol intake;
- Subject has uncontrolled hypertension; Subject has poorly controlled diabetes;
- Subject is pregnant, lactating, or is planning to become pregnant during the study (both male and female); subject has positive pregnancy test result; subject is unable to practice highly effective contraception methods during the trial and within 3 months after the end of the trial;
- Subject is currently enrolled or was enrolled in other clinical trials within 3 months prior to the initiation of treatment;
- Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital, Fudan University
Shanghai
Shuyang Zhao, 13123927303, zhaoshuyang@wsh.3sbio.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Clinical Study to Evaluate the Efficacy and Safety of Clascoterone Cream 1% in Treatment of Subjects With Facial Acne Vulgaris
The primary objective of this study is to determine the safety and efficacy of clascoterone cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Clascoterone, Vehicle cream
- Keywords
- Acne Vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClascoteroneDrug
Also called Winlevi (brand name)
Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Vehicle creamDrug
Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Clascoterone Cream 1% | Experimental | Clascoterone Cream 1% (Winlevi) Receives: Drug: Clascoterone |
| Vehicle cream | Placebo comparator | Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient. Receives: Drug: Vehicle cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)
Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.
Measured: Week 12
Change From Baseline in Non-inflammatory Lesion (NIL) Counts
Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Measured: Week 12
Change From Baseline in Inflammatory Lesion (IL) Counts
Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
Measured: Week 12
Secondary outcomes (4)
Change From Baseline in Total Lesion Counts
Absolute change from Baseline in total lesions counts in each treatment group at Week 12.
Measured: Week 12
Percent Change From Baseline in Total Lesion Counts
Percent change from Baseline in total lesions counts in each treatment group at Week 12.
Measured: Week 12
Percent Change From Baseline in Inflammatory Lesion Counts
Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.
Measured: Week 12
Percent Change From Baseline in Non-inflammatory Lesion Counts
Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.
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 posted8 May 2024
- Study start20 May 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 692 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403501
- Sponsor's protocol ID
- LWY23090C
- Status last verified
- Jul 2025
- First submitted
- 30 Apr 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Clinical Study to Evaluate the Efficacy and Safety of Clascoterone Cream 1% in Treatment of Subjects With Facial Acne Vulgaris
- ClinicalTrials.gov ID
- NCT06403501
- Acronym / sponsor ID
- LWY23090C
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 692 participants (estimated)
- Lead sponsor
- Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 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.
The primary objective of this study is to determine the safety and efficacy of clascoterone cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clascoterone Cream 1% | Experimental | Drug: ClascoteroneClascoterone Cream 1% (Winlevi) |
| Vehicle cream | Placebo comparator | Drug: Vehicle creamVehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with facial acne vulgaris (which includes the nose) from moderate to severe, has an Investigator's Global Assessment (IGA) score of 3 or 4; with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones);
- Male or female, 12 years of age or older;
- Subjects aged 18 years or older are required to provide informed consent and sign the written informed consent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of consent signing.
Key exclusion criteria (13 listed)
- Subject has greater than two (2) facial nodules;
- Subject has any skin pathology or condition that could interfere with the investigator's clinical evaluation of the investigational drug;
- Subject has used topical and systemic anti-acne medications or therapies;
- Subject has received hormonal therapy for acne treatment;
- Subject has used a skincare product with acne removal effect;
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 |
|---|---|---|
| ClascoteroneAlso: Winlevi (brand name)Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. | Drug | Clascoterone Cream 1% |
| Vehicle creamVehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient. | Drug | Vehicle cream |
Primary outcome
Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)
Time frame: Week 12
Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.
Change From Baseline in Non-inflammatory Lesion (NIL) Counts
Time frame: Week 12
Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Change From Baseline in Inflammatory Lesion (IL) Counts
Time frame: Week 12
Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
4 secondary outcomes
Change From Baseline in Total Lesion Counts
Time frame: Week 12
Percent Change From Baseline in Total Lesion Counts
Time frame: Week 12
Percent Change From Baseline in Inflammatory Lesion Counts
Time frame: Week 12
Percent Change From Baseline in Non-inflammatory Lesion Counts
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 9 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clascoterone in people with Acne Vulgaris, run by Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. at 1 site in China.
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 3 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 9 Jul 2025. 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 China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA) (time frame: Week 12). The study lists 3 primary outcomes in all. 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 9 Jul 2025.