At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 807 enrolled
Drug / intervention
Trifarotene 0.005 % Topical Cream +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, THREE-ARM, PLACEBO CONTROLLED, PARALLEL-DESIGN GROUP STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE COMPARING TRIFAROTENE CREAM, 0.005% (TEVA PHARMACEUTICALS, INC. TO AKLIEF ® (TRIFAROTENE 0.005% CREAM) (GALDERMA LABORATORIES, L.P., USA), IN THE TREATMENT OF ACNE VULGARIS
In Brief
A Phase 3 clinical trial evaluating Trifarotene 0.005 % Topical Cream, AKLIEF®, and 1 other intervention for Acne Vulgaris. Completed, enrolled 807 participants across 14 sites.
Detailed Summary
To compare the safety and efficacy of the test (Trifarotene 0.005% cream), placebo (vehicle cream) and reference AKLIEF® (Trifarotene 0.005% cream) treatments to demonstrate clinical equivalence in subjects with acne vulgaris.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesUnited States
CollaboratorsTeva Pharmaceuticals, Inc.
Timeline
Phase 3CompletedFinished
2023202420252026
Enrollment StartSep 2022
First PostedSep 2022
Primary CompletionMay 2023
TodayJul 2026
First PostedSep 22, 2022
Enrollment StartSep 19, 2022
Primary CompletionMay 9, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.8 years ago
Interventions
Trifarotene 0.005 % Topical Creamdrug
Cream
AKLIEF®drug
Cream
Placebodrug
Cream