New acne cream could be Game-Changer for teens and adults
NCT ID NCT07457294
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests a cream called clascoterone (1%) against a placebo in 692 people aged 12 and older with moderate to severe acne. Participants apply the cream to their face twice daily for 12 weeks. The goal is to see if the cream clears acne better than a placebo, with fewer side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 1% clascoterone cream
- What this could lead to
- If it works, this could provide a new topical treatment option for moderate to severe acne, reducing pimples and skin inflammation.
- What could go wrong
- This is a Phase 3 trial, but it hasn't started yet. The cream may not work better than placebo, and side effects like skin irritation are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 692 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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