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NCT04451330 · ClinicalTrials.gov registry record · Phase 4
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 Phase 4 study of Acne Vulgaris, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 4
- Development phase
- 202
- Enrollment target
- 20
- Study locations
NCT04451330: Completed Phase 4 study of Acne Vulgaris, sponsored by Galderma R&D.
NCT04451330 is a Phase 4 study of Acne Vulgaris that has completed, run by Galderma R&D. The registered enrollment target is 202 participants, below the 272-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04451330, a Phase 4 study of Acne Vulgaris, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 202 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face.
Conditions Studied
Interventions
- DRUG Trifarotene cream
- DRUG Doxycycline hyclate
- DRUG Trifarotene Vehicle
- DRUG Doxycycline Placebo
Study Locations (20)
Arkansas
- Galderma Investigational Site - Fort Smith
- Galderma Investigational Site - Hot Springs
- Galderma Investigational Site - Rogers
Florida
- Galderma Investigational Site - Aventura
- Galderma Investigational Site - Boca Raton
- Galderma Investigational Site - Miramar
Indiana
- Galderma Investigational Site - Evansville
- Galderma Investigational Site - New Albany
California
- Galderma Investigational Site - Newport Beach
Georgia
- Galderma Investigational Site - Newnan
Maryland
- Galderma Investigational Site - Rockville
Michigan
- Galderma Investigational Site - Warren
Minnesota
- Galderma Investigational Site - New Brighton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2021-04-26 |
| Phase | Phase 4 |
What the finished NCT04451330 record still lists
NCT04451330 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 272-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 4 interventions - of which Trifarotene cream is the first listed.
NCT04451330 names 20 study sites across 15 states, led by Arkansas, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT04451330 about?
NCT04451330 is a clinical study titled "A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)". 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.
What is the current status of trial NCT04451330?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 202 participants. The study started on 2020-07-29. Estimated completion is 2021-04-26.
What conditions does trial NCT04451330 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT04451330?
The interventions under investigation include: Trifarotene cream (DRUG), Doxycycline hyclate (DRUG), Trifarotene Vehicle (DRUG), Doxycycline Placebo (DRUG).
Who is sponsoring clinical trial NCT04451330?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04451330 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04451330's enrollment target sits among peer trials
202 28th of 67 higher than 40 of 67 other Acne Vulgaris trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acne Vulgaris trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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