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A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
NCT04451330 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04451330
The ClinicalTrials.gov registry entry for NCT04451330 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Galderma R&D, which has 49 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04451330 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Arkansas, Florida, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04451330?
This trial is sponsored by Galderma R&D, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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