CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 202 enrolled
Drug / intervention
Trifarotene cream +3 moredrug
Likely dose
Trifarotene cream 50 mcgfrom 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.

Search/NCT04451330
NCT04451330Phase 4Completed
CompareCT.gov

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study To Compare Efficacy and Safety of Trifarotene (CD5789) Cream When Used Withan Oral Antibiotic for the Treatment of Severe Acne Vulgaris

Galderma R&D·interventional·Posted Jun 30, 2020·Updated May 10, 2022

In Brief

A Phase 4 clinical trial evaluating Trifarotene cream, Doxycycline hyclate, and 2 other interventions for Acne Vulgaris. Completed, enrolled 202 participants across 26 sites in 2 countries.

Detailed Summary

The purpose of this study was to demonstrate that daily use of topical trifarotene (CD5789) 50 microgram per gram (mcg/g) cream when used in association with oral antibiotic is safe and effective for the treatment of severe AV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJun 30, 2020
Enrollment StartJul 29, 2020
Primary CompletionApr 26, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.0 years ago

Interventions

Trifarotene creamdrug

Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.

Doxycycline hyclatedrug

Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.

Trifarotene Vehicledrug

Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.

Doxycycline Placebodrug

Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.