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NCT01616654 · ClinicalTrials.gov registry record · Phase 2
Dose Range Study of CD5789 in Acne Vulgaris
A Phase 2 study of Acne Vulgaris, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 304
- Enrollment target
- 20
- Study locations
NCT01616654: Completed Phase 2 study of Acne Vulgaris, sponsored by Galderma R&D.
NCT01616654 is a Phase 2 study of Acne Vulgaris that has completed, run by Galderma R&D. The registered enrollment target is 304 participants, above the 271-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01616654, a Phase 2 study of Acne Vulgaris, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 304 participants
- Enrollment target
- 20
- Study locations
Study Summary
To assess the efficacy and safety of different concentrations of CD5789 cream in participants with acne vulgaris for the purpose of dose identification.
Primary Outcome
Success Rate 1 was defined as percentage of participants who achieved at least a two-point reduction in the Investigator Global Assessment (IGA) scale from baseline at week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).
Conditions Studied
Interventions
- DRUG Vehicle cream
- DRUG CD5789 25 µg/g cream
- DRUG CD5789 50 µg/g cream
- DRUG CD5789 100 µg/g cream
- DRUG Tazarotene 0.1% gel
Study Locations (20)
California
- Parexel Early Phase - Glendale
- Odyssey Medispa - Marina del Rey
- Rady Children's Hospital - San Diego
Florida
- FXM Research Corp Miami - Miami
- FMX Research Miramar - Miramar
Michigan
- Hamzavi Dermatology - Fort Gratiot
- Somerset Skin Centre - Troy
North Carolina
- Zoe Drealos, MD - High Point
- PMG Research of Wilmington - Wilmington
Texas
- Arlington Center for Dermatology - Arlington
- Suzanne Bruce and Associates P.A. The Center for Skin Research - Houston
Alabama
- Total Skin and Beauty Dermatology Center, PC - Birmingham
Georgia
- Meda Phase, Inc - Newnan
Indiana
- Deaconess Clinic, Inc. - Evansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2012-06-20 |
| Est. Completion | 2014-06-12 |
| Phase | Phase 2 |
What the finished NCT01616654 record still lists
NCT01616654 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, above the 271-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (12% higher).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 5 interventions - of which Vehicle cream is the first listed.
NCT01616654 names 20 study sites across 14 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT01616654 about?
NCT01616654 is a clinical study titled "Dose Range Study of CD5789 in Acne Vulgaris". To assess the efficacy and safety of different concentrations of CD5789 cream in participants with acne vulgaris for the purpose of dose identification.
What is the current status of trial NCT01616654?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 304 participants. The study started on 2012-06-20. Estimated completion is 2014-06-12.
What conditions does trial NCT01616654 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT01616654?
The interventions under investigation include: Vehicle cream (DRUG), CD5789 25 µg/g cream (DRUG), CD5789 50 µg/g cream (DRUG), CD5789 100 µg/g cream (DRUG), Tazarotene 0.1% gel (DRUG).
Who is sponsoring clinical trial NCT01616654?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01616654 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01616654's enrollment target sits among peer trials
304 24th of 67 higher than 44 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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