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NCT05089708 · ClinicalTrials.gov registry record · Phase 4
AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation
A Phase 4 study of Acne Vulgaris, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 4
- Development phase
- 123
- Enrollment target
- 20
- Study locations
NCT05089708: Completed Phase 4 study of Acne Vulgaris, sponsored by Galderma R&D.
NCT05089708 is a Phase 4 study of Acne Vulgaris that has completed, run by Galderma R&D. The registered enrollment target is 123 participants, below the 274-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05089708, a Phase 4 study of Acne Vulgaris, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 123 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of Trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle cream in the treatment of moderate acne vulgaris with risk of acne-induced post inflammatory hyperpigmentation (PIH) after 24 weeks of treatment in facial acne participants
Primary Outcome
The PIH ODS Score is based on a 9-point scale: Grade 0 Normal; Grade 1 Present, but \<mild; Grade 2 Mild (slightly noticeable); Grade 3 Between mild and moderate; Grade 4 Moderate; Grade 5 Between moderate and marked; Grade 6 Marked (distinctive); Grade 7 Between marked and severe; Grade 8 Severe (very distinctive). A negative change indicates a reduction from in PIH disease severity score from baseline.
Conditions Studied
Interventions
- DRUG Trifarotene Cream
- DRUG Trifarotene Vehicle Cream
Study Locations (20)
California
- Galderma Investigational Site #8636 - Fountain Valley
- Galderma Investigational Site #8224 - Fremont
- Galderma Investigational Site #8358 - San Diego
- Galderma Investigational Site #9955 - San Diego
Florida
- Galderma Investigational Site #7012 - Lutz
- Galderma Investigational Site #8184 - Maitland
- Galderma Investigational Site #8764 - Tampa
New York
- Galderma Investigational Site #8620 - New York
- Galderma Investigational Site #9956 - New York
- Galderma Investigational Site #9949 - New York
Louisiana
- Galderma Investigational Site #9952 - Baton Rouge
- Galderma Investigational Site #8606 - New Orleans
Maryland
- Galderma Investigational Site #8012 - Glenn Dale
- Galderma Investigational Site #9948 - Hyattsville
Indiana
- Galderma Investigational Site #9950 - Evansville
Michigan
- Galderma Investigational Site #8554 - Detroit
Nevada
- Galderma Investigational Site #8108 - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2021-12-22 |
| Est. Completion | 2022-12-15 |
| Phase | Phase 4 |
What the finished NCT05089708 record still lists
NCT05089708 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 274-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 2 interventions - of which Trifarotene Cream is the first listed.
NCT05089708 names 20 study sites across 11 states, led by California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT05089708 about?
NCT05089708 is a clinical study titled "AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation". The purpose of this study is to evaluate the efficacy and safety of Trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle cream in the treatment of moderate acne vulgaris with risk of acne-induced post inflammatory hyperpigmentation (PIH) after 24 weeks of treatment in facial acne ...
What is the current status of trial NCT05089708?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 123 participants. The study started on 2021-12-22. Estimated completion is 2022-12-15.
What conditions does trial NCT05089708 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT05089708?
The interventions under investigation include: Trifarotene Cream (DRUG), Trifarotene Vehicle Cream (DRUG).
Who is sponsoring clinical trial NCT05089708?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05089708 being conducted?
This trial has 20 study locations across California, Florida, Indiana, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acne Vulgaris
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05089708's enrollment target sits among peer trials
123 36th of 67 higher than 31 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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