Acne VulgarisPhase 3NCT07457294
1% Clascoterone Cream for the Treatment Acne Vulgaris
A Phase 3 study testing 1% Clascoterone Cream in people with Acne Vulgaris, run by Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd..
Trial summary
This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of 1% Clascoterone Cream in the treatment of 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?
- 1% Clascoterone Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 692 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2026to 7 Feb 2029
- 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
- Participants who are able to understand and comply with the protocol, voluntarily participate in the study, and sign the written informed consent form (ICF); for a participant aged <18 years, the written ICF must be co-signed by the minor participant and a parent or legal guardian based on informed consent;
- Age ≥12 years at the time of ICF signing, regardless of gender;
- Diagnosis of moderate to severe acne vulgaris (including the nose) at screening and randomization, with an IGA score of 3 or 4, and facial lesions meeting the following criteria: 30-75 inflammatory lesions (papules, pustules, and nodules) and 30-100 non-inflammatory lesions (open and closed comedones);
- Participants have used the same brand and type of skin and hair care products for at least 2 weeks prior to randomization and agree to continue the current products and regimen during the study period;
- Female participants of childbearing potential (and their male partners) and male participants (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose of the study drug . Participants must have no plans for conception, sperm donation, or egg donation throughout the study period and for at least 3 months after the last dose of the study drug.
Who cannot join
- Participants have more than 2 facial nodules at screening or randomization;
- Participants have facial cysts at screening or randomization;
- Participants have conditions at screening or randomization, which may interfere with the investigator's clinical assessments, including but not limited to: 1) Other facial dermatoses: specific types of acne (e.g., nodulocystic acne, acne conglobata, acne fulminans, etc.), secondary acne (e.g., drug-induced acne, mechanical acne, occupational acne, chloracne, etc.), or other facial rashes due to different conditions (e.g., rosacea, seborrheic dermatitis, solar dermatitis, lupus miliaris disseminatus faciei, psoriasis, eczema, etc.); 2) Facial skin or hair conditions that may interfere with clinical assessments (e.g., prominent beard, sideburns, whiskers, etc.);
- Participants have systemic diseases with associated skin lesions: e.g., inflammatory bowel disease (Crohn's disease and ulcerative colitis), SAHA syndrome (seborrhea-acne-hirsutism-androgenetic alopecia syndrome), PCOS syndrome (polycystic ovary syndrome), SAPHO syndrome (synovitis-acne-pustulosis-hyperostosis-osteomyelitis), PAPA syndrome (pyogenic sterile arthritis-pyoderma gangrenosum-acne syndrome), hyperandrogenism-insulin resistance-acanthosis nigricans syndrome, congenital adrenal hyperplasia, etc.;
- Prior use of the topical acne medications or therapies or Use of the systemic medications；
- Use of skin care products with anti-acne efficacy within 2 weeks prior to randomization;
- Participants have any serious or unstable medical condition that, in the investigator's judgment, may affect the participant's safety during the study and/or impede study completion, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, or psychiatric disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of 1% Clascoterone Cream in the Treatment of Acne Vulgaris
This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of 1% Clascoterone Cream in the treatment of acne vulgaris.
Target population: Participants aged ≥12 years with moderate to severe acne vulgaris who meet the inclusion criteria and none of the exclusion criteria.
Treatment: The investigational group will receive 1% Clascoterone Cream, and the control group will receive placebo. Approximately 1 g of the cream will be applied evenly to the entire face twice daily (morning and evening) for 12 weeks.
- Conditions
- Acne Vulgaris
- Being tested
- 1% Clascoterone Cream, Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Clascoterone CreamDrug
1% Clascoterone Cream applied topically to affected areas twice daily for the duration of the study.
PlaceboDrug
Placebo cream, matching the 1% Clascoterone Cream in appearance, texture, and scent, applied topically to affected areas twice daily for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| 1% Clascoterone Cream | Experimental | Not described Receives: Drug: 1% Clascoterone Cream |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
P1: Proportion of participants achieving "success" at Week 12 ("success" is defined as an Investigator's Global Assessment (IGA) score of 0 or 1, with at least a 2-point reduction from baseline);
Measured: Week 12
Secondary outcomes (8)
Proportion of participants achieving "success" at Week 4 and Week 8
Measured: Week 4 and Week 8
Absolute change from baseline in NILC at Week 4 and Week 8
Measured: Week 4 and Week 8
Absolute change from baseline in ILC at Week 4 and Week 8
Measured: Week 4 and Week 8
Absolute change from baseline in total lesion count (inflammatory and non-inflammatory lesions) at Week 4, Week 8, and Week 12
Measured: Week 4, Week 8, and Week 12
Percent change from baseline in total lesion count at Week 4, Week 8, and Week 12
Measured: Week 4, Week 8, and Week 12
Percent change from baseline in ILC at Week 4, Week 8, and Week 12
Measured: Week 4, Week 8, and Week 12
Percent change from baseline in NILC at Week 4, Week 8, and Week 12
Measured: Week 4, Week 8, and Week 12
Safety: Incidence of adverse events
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 posted9 Mar 2026
- Study start4 May 2026 (estimated)
- Primary completion7 Aug 2028 (estimated)
- Study completion7 Feb 2029 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT07457294
- Sponsor's protocol ID
- P-WS204(cream)-LC
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the nature of the study and privacy concerns, de-identified individual participant data will not be made available to external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of 1% Clascoterone Cream in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07457294
- Acronym / sponsor ID
- P-WS204(cream)-LC
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 692 participants (estimated)
- Lead sponsor
- Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 May 2026 (estimated)
- Primary completion
- 7 Aug 2028 (estimated)
- Study completion
- 7 Feb 2029 (estimated)
- First posted
- 9 Mar 2026 (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.
This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of 1% Clascoterone Cream in the treatment of acne vulgaris.
Target population: Participants aged ≥12 years with moderate to severe acne vulgaris who meet the inclusion criteria and none of the exclusion criteria.
Treatment: The investigational group will receive 1% Clascoterone Cream, and the control group will receive placebo. Approximately 1 g of the cream will be applied evenly to the entire face twice daily (morning and evening) for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1% Clascoterone Cream | Experimental | Drug: 1% Clascoterone Cream |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who are able to understand and comply with the protocol, voluntarily participate in the study, and sign the written informed consent form (ICF); for a participant aged <18 years, the written ICF must be co-signed by the minor participant and a parent or legal guardian based on informed consent;
- Age ≥12 years at the time of ICF signing, regardless of gender;
- Diagnosis of moderate to severe acne vulgaris (including the nose) at screening and randomization, with an IGA score of 3 or 4, and facial lesions meeting the following criteria: 30-75 inflammatory lesions (papules, pustules, and nodules) and 30-100 non-inflammatory lesions (open and closed comedones);
- Participants have used the same brand and type of skin and hair care products for at least 2 weeks prior to randomization and agree to continue the current products and regimen during the study period;
- Female participants of childbearing potential (and their male partners) and male participants (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose of the study drug . Participants must have no plans for conception, sperm donation, or egg donation throughout the study period and for at least 3 months after the last dose of the study drug.
Key exclusion criteria (7 listed)
- Participants have more than 2 facial nodules at screening or randomization;
- Participants have facial cysts at screening or randomization;
- Participants have conditions at screening or randomization, which may interfere with the investigator's clinical assessments, including but not limited to: 1) Other facial dermatoses: specific types of acne (e.g., nodulocystic acne, acne conglobata, acne fulminans, etc.), secondary acne (e.g., drug-induced acne, mechanical acne, occupational acne, chloracne, etc.), or other facial rashes due to different conditions (e.g., rosacea, seborrheic dermatitis, solar dermatitis, lupus miliaris disseminatus faciei, psoriasis, eczema, etc.); 2) Facial skin or hair conditions that may interfere with clinical assessments (e.g., prominent beard, sideburns, whiskers, etc.);
- Participants have systemic diseases with associated skin lesions: e.g., inflammatory bowel disease (Crohn's disease and ulcerative colitis), SAHA syndrome (seborrhea-acne-hirsutism-androgenetic alopecia syndrome), PCOS syndrome (polycystic ovary syndrome), SAPHO syndrome (synovitis-acne-pustulosis-hyperostosis-osteomyelitis), PAPA syndrome (pyogenic sterile arthritis-pyoderma gangrenosum-acne syndrome), hyperandrogenism-insulin resistance-acanthosis nigricans syndrome, congenital adrenal hyperplasia, etc.;
- Prior use of the topical acne medications or therapies or Use of the systemic medications；
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 |
|---|---|---|
| 1% Clascoterone Cream1% Clascoterone Cream applied topically to affected areas twice daily for the duration of the study. | Drug | 1% Clascoterone Cream |
| PlaceboPlacebo cream, matching the 1% Clascoterone Cream in appearance, texture, and scent, applied topically to affected areas twice daily for the duration of the study. | Drug | Placebo |
Primary outcome
P1: Proportion of participants achieving "success" at Week 12 ("success" is defined as an Investigator's Global Assessment (IGA) score of 0 or 1, with at least a 2-point reduction from baseline);
Time frame: Week 12
8 secondary outcomes
Proportion of participants achieving "success" at Week 4 and Week 8
Time frame: Week 4 and Week 8
Absolute change from baseline in NILC at Week 4 and Week 8
Time frame: Week 4 and Week 8
Absolute change from baseline in ILC at Week 4 and Week 8
Time frame: Week 4 and Week 8
Absolute change from baseline in total lesion count (inflammatory and non-inflammatory lesions) at Week 4, Week 8, and Week 12
Time frame: Week 4, Week 8, and Week 12
Percent change from baseline in total lesion count at Week 4, Week 8, and Week 12
Time frame: Week 4, Week 8, and Week 12
Percent change from baseline in ILC at Week 4, Week 8, and Week 12
Time frame: Week 4, Week 8, and Week 12
Percent change from baseline in NILC at Week 4, Week 8, and Week 12
Time frame: Week 4, Week 8, and Week 12
Safety: Incidence of adverse events
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 Mar 2026.
- Individual participant dataSharing planned: No. Due to the nature of the study and privacy concerns, de-identified individual participant data will not be made available to external researchers.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1% Clascoterone Cream in people with Acne Vulgaris, run by Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd..
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jie Wang (+86 13140705482, wangjie13@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P1: Proportion of participants achieving "success" at Week 12 ("success" is defined as an Investigator's Global Assessment (IGA) score of 0 or 1, with at least a 2-point reduction from baseline); (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 9 Mar 2026.