Trial · NCT07186413
A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris
NCT07186413, Phase 3, Active not recruiting, Galderma R&D
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris. Trials, record NCT07186413. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07186413
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris
- NCT number
- NCT07186413
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 561 participants, estimated
- Lead sponsor
- Galderma R&D
- Conditions
- Acne Vulgaris
- Interventions
- Trifarotene, Vehicle Cream
- First posted
- 2025-09-22
- Last updated
- 2026-08-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants with Investigator Global Assessment (IGA) Success (Face only) at Week 12 | Baseline to Week 12 | The areas defined for IGA assessment are the forehead, each cheek, chin, and nose. IGA will be confined to a global assessment of each area defined above. IGA consists of 5 grades ranging from 0-4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Success Rate, defined as the percentage of participants who achieve an IGA score (face only) of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12. |
| Primary | Change from Baseline to Week 12 in Facial Non-inflammatory Lesion Count | Baseline to Week 12 | |
| Primary | Change from Baseline to Week 12 in Facial Inflammatory Lesion Count | Baseline to Week 12 | |
| Secondary | Percentage of Participants with Physician Global Assessment (PGA) Success at Week 12 | Baseline to Week 12 | The areas defined for PGA assessment are shoulders, upper back and upper anterior chest which are accessible to self-application by the participants. PGA will be confined to a global assessment of each areas defined above. The PGA is a snapshot static assessment to be done prior to detailed lesion counts. PGA consists of 5 grades ranging from 0-4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. PGA Success, defined as the percentage of participants who achieve a PGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12 |
| Secondary | Change from Baseline to Week 12 in Truncal Non-inflammatory Lesion Count | Baseline to Week 12 | |
| Secondary | Change from Baseline to Week 12 in Truncal Inflammatory Lesion Count | Baseline to Week 12 | |
| Secondary | Number of Participants With Adverse Events (AEs), Including AEs of Special Interest (AESIs), Treatment-emergent AEs (TEAEs), and Serious AEs (SAEs) | Baseline to Week 12 | |
| Secondary | Investigator's Local Tolerability Assessment | Baseline, Weeks 1, 2, 4, 8 and 12 | Local tolerability, which includes individual assessment of erythema, scaling, dryness, and stinging/burning, will be graded on a 4-point scale (ranging from 0 \[None\] to 3 \[Severe\]) separately for the face and trunk. A higher score indicated a severe outcome. The areas for evaluation on the face include the forehead, nose, chin, and right and left cheeks. The areas for evaluation on the upper trunk include the shoulders, right and left chest, and right and left upper back, which are accessible to self-application by the subject. If IP is applied to the middle and/or lower back, the local tolerability assessment of the trunk will include the upper, middle, and/or lower back, if applicable, and will be analyzed as 1 area. |
| Secondary | Observed Plasma Concentration (Ct) in Selected Participants | Baseline, Week 4 and Week 12 | Three PK samples will be collected to inform trifarotene exposure in adult participants. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07186413
GET https://conductscience.org/api/trials/v1/NCT07186413/registered