Phase 3
Completed N=1,212
Double-Blind Efficacy and Safety of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream in Acne Vulgaris
Source: ClinicalTrials.gov NCT02556788 ↗Enrolled (actual)
1,212
Serious AEs
0.5%
Results posted
Sep 2019
Primary outcomePrimary: Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) — 255; 157 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Assessment of the efficacy and safety of CD5789 (Trifarotene) 50µg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear) |
255; 157 | — |
Eligibility Criteria
Inclusion Criteria
- The subject is a male or female, 9 years of age or older, at Screening visit.
- The Subject has moderate acne at Screening and Baseline.
- The subject is a female of non childbearing potential
- The subject is a female of childbearing potential with a negative pregnancy test and who is strictly abstinent or who agrees to use an effective and approved contraceptive method for the duration of the study and at least 1 month after the last study drug application.
Exclusion Criteria
- The subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.).
- The subject has any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part to the trial.
- The subject has been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the subject is planning intense UV exposure during the study (i.e., occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.)
- The subject is unwilling to refrain from use of prohibited medication during the clinical trial
Data sourced from ClinicalTrials.gov (NCT02556788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.