New acne cream shows promise in chinese trial
NCT ID NCT07186413
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times
Summary
This study tests a cream called trifarotene on Chinese people aged 9 and older with moderate acne on the face and upper body. About 561 participants will apply the cream or a placebo daily for 12 weeks. The goal is to see if the cream reduces acne lesions and improves skin appearance.
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 561 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2026
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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9 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 must meet the following criteria to be included in the study: 1. Male or female Chinese participants aged 9 years or older at the screening visit. 2. A minimum of 20 inflammatory lesions and 25 non-inflammatory lesions on the face at Screening and Baseline. 3. Facial acne vulgaris severity grade 3 (moderate) on the IGA scale at Screening and Baseline. 4. A minimum of 20 inflammatory lesions and 20 non-inflammatory lesions but no more than 100 non-inflammatory lesion counts on the trunk (shoulders, upper back, and upper anterior chest) reachable for self-application of investigational product by the participant at Screening and Baseline (optional criterion for participant between 9 and 11 years of age). 5. Acne vulgaris severity grade 3 (moderate) on the PGA scale at Screening and Baseline visits on trunk (shoulders, upper back and upper anterior chest) reachable for self-application of investigational product by the participant (optional criterion for participants between 9 and 11 years of age). 6. Female participants of non-childbearing potential, i.e., premenstrual, or postmenopausal. Postmenopausal participants must meet one criterion at Screening: * Absence of menstrual bleeding for 1 year before screening with no other medical reason, confirmed with follicle-stimulating hormone level in the postmenopausal range. * Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before Screening. 7. Female participants of childbearing potential (i.e., fertile, after menarche and until becoming postmenopausal unless permanently sterile) must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test (UPT) at the baseline visit (with a sensitivity of 25 international units per litre \[IU/L\] or less). They must use at least 1 adequate and approved method of contraception throughout the study and for 1 month after the last dose of investigational product. 8. Premenstrual participants who start menses during the study must use at least 1 adequate and approved method of contraception throughout the study and for 1 month after the last dose of investigational product. 9. Willing and able to comply with all the time commitments and procedural requirements of the clinical study protocol. 10. Understands and signs an informed consent form (ICF) at the screening visit, before any investigational procedures are performed. 11. Participants who are younger than 18 years of age and whose parent/legal representative is willing/able to comply with the study requirements and understand/sign the ICF at the screening visit, before any investigational procedures are performed, will sign the assent ICF at the screening visit. 12. At selected clinical sites: If a participant who is 18 years of age or older at the screening visit and agrees to participate in study photographs, verified by dating and signing a separate approved photography ICF. For participants younger than 18 years of age, an assent photography ICF signed by the participant in conjunction with a photography ICF signed by the parents(s)/legal representative at the screening visit. 13. Participant is informed of terms pertaining to personal information protection and privacy and is willing to share personal information and data, in accordance with local regulations. Exclusion Criteria: Participants meeting the following criteria at the screening or baseline visits are ineligible to participate in this study: 1. Pregnant women (positive serum pregnancy test result at the screening visit or positive UPT at the baseline visit), breastfeeding women, or women planning a pregnancy during the study or within 1 month after the last investigational product application. 2. Severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g., chloracne, drug-induced acne) at the screening and baseline visits. 3. More than 1 nodule on the face at the screening and baseline visits. 4. More than 1 nodule on the trunk at the screening and baseline visits. 5. Any acne cyst on the face at the screening and baseline visits. 6. Any acne cyst on the trunk at the screening and baseline visits. 7. Facial or truncal hair that may interfere with the study assessments according to investigator's judgment. 8. Abnormal pigmentation, wound, scar, or tattoo on the face or on the shoulders, upper back, or chest that may interfere with the study assessments according to investigator's judgment. 9. Any uncontrolled or serious disease or any medical or surgical condition that may interfere with the interpretation of the study results and/or put the participant at significant risk according to investigator's judgment. 10. Abnormal laboratory test results at the screening visit (hematology, comprehensive metabolic panel, and urinalysis) judged as clinically significant by the investigator (to be checked before the baseline visit), which may interfere with the interpretation of the study results and/or put the participant at significant risk (e.g., elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (\> 3 × upper limit of normal \[ULN\])). 11. Known allergies or hypersensitivities to any component of the formulation of the investigational products (trifarotene 50 mcg/g cream or vehicle cream; see Investigator's Brochure). 12. Previously participated in any trifarotene cream clinical study. 13. Current participation in any other clinical study of a drug or device OR past participation within 30 days before the baseline visit. 14. Alcohol or drug abuse or substance dependence within 12 months before the screening visit. 15. Inability or unwillingness to undergo multiple venipunctures because of poor tolerability or venous access. 16. Loss of over 500 mL of blood or blood donation within the last 3 months before the screening visit. 17. Having received prohibited medication or treatment during the study. 18. Exposure to excessive ultraviolet (UV) radiation within 1 month before the baseline visit. 19. Unwillingness to avoid excessive or prolonged exposure to UV light (i.e., occupational exposure to the sun, sunbathing, tanning bed use, phototherapy) throughout the study. 20. Any drug that in the opinion of the investigator may interfere with the study assessments or exacerbate acne, i.e., lithium, halogens, haloperidol, hydantoin, phenobarbital, Vitamin B12, androgens. 21. Unwillingness to refrain from prohibited medication during the clinical study as defined by protocol. 22. Participant vulnerability (such as freedom deprivation, mental disease, those incapable of giving consent) as defined in Section 1.61 of the International Council for Harmonization Guideline for Good Clinical Practice (GCP). 23. More than 1 participant sharing the same household. 24. Clinical site personnel, close relatives of the clinical site personnel (e.g., parents, children, siblings, or spouse), employees, or close relatives of employees of the Sponsor company.
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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.
Contacts and locations
Locations
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Galderma Research & Development Site #5378
Shanghai, Jing'an District, China
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Other studies related to the condition(s) this trial covers.
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