Phase 3
Completed N=453
CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris
Source: ClinicalTrials.gov NCT02189629 ↗Enrolled (actual)
453
Serious AEs
2.2%
Results posted
Sep 2019
Primary outcomePrimary: Investigator Global Assessment (IGA) Success Rate up to Week 52 — 453 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 This can indicate results are unpublished — a known publication-bias signal.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
Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of treatment on the face and trunk for acne vulgaris.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator Global Assessment (IGA) Success Rate up to Week 52 |
453 | — |
| SECONDARY Physician Global Assessment (PGA) Success Rate up to Week 52 |
453 | — |
Eligibility Criteria
Inclusion Criteria
- The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening and Baseline visits.
- The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at Screening and Baseline visits on the face.
- Exclusion Criteria:
- The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.).
- The Subject has more than 1 nodule on the face at Screening and at Baseline visits.
- The Subject has any acne cyst on the face at Screening and at Baseline visits.
Data sourced from ClinicalTrials.gov (NCT02189629). 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.