Trials / Completed
CompletedNCT04451330
A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 202 (actual)
- Sponsor
- Galderma R&D · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Trifarotene cream | Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks. |
| DRUG | Doxycycline hyclate | Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks. |
| DRUG | Trifarotene Vehicle | Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks. |
| DRUG | Doxycycline Placebo | Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks. |
Timeline
- Start date
- 2020-07-29
- Primary completion
- 2021-04-26
- Completion
- 2021-04-26
- First posted
- 2020-06-30
- Last updated
- 2022-05-10
- Results posted
- 2022-05-10
Locations
26 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04451330. Inclusion in this directory is not an endorsement.