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NCT01494467 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Papulopustular Rosacea Study
A Phase 3 study of Papulopustular Rosacea, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 688
- Enrollment target
- 20
- Study locations
NCT01494467: Completed Phase 3 study of Papulopustular Rosacea, sponsored by Galderma R&D.
NCT01494467 is a Phase 3 study of Papulopustular Rosacea that has completed, run by Galderma R&D. The registered enrollment target is 688 participants, above the 217-participant average among 11 other Papulopustular Rosacea trials with a reported enrollment target (217% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01494467, a Phase 3 study of Papulopustular Rosacea, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 688 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.
Primary Outcome
Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale: Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or la
Conditions Studied
Interventions
- DRUG CD5024
- DRUG Azelaic acid 15% Gel
Study Locations (20)
California
- Dermatology Specialists, Inc - Oceanside
- Integrated Research Group, Inc - Riverside
- Therapeutics Clinical Research - San Diego
- University of California, San Francisco - San Francisco
- ATS Clinical Research - Santa Monica
- Redwood Dermatology Research - Santa Rosa
Alabama
- Total Skin and Beauty - Birmingham
- Coastal Clinical Research, Inc. - Mobile
Florida
- FXM Research Corp Miami - Miami
- Leavitt Medical Associates of Florida dba Ameriderm Research - Ormond Beach
Georgia
- Atlanta Dermatology, Vein & Research Center, LLC - Alpharetta
- Emory University - Atlanta
Illinois
- Altman Dermatology Associates - Arlington Heights
- Northwestern University - Chicago
Indiana
- Deaconess Clinic, Inc. - Evansville
- Dawes Fretzin Clinical Research Group, LLC - Indianapolis
Arkansas
- Burke Pharmaceutical Research - Hot Springs
Kentucky
- Dermatology Specialists Research - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 688 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
What the finished NCT01494467 record still lists
NCT01494467 is an interventional study that assigns participants to a tested intervention. The registered 688 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 11 other Papulopustular Rosacea trials with a reported enrollment target (217% higher).
The record links to 1 condition, with Papulopustular Rosacea appearing as the primary indexed condition, and to 2 interventions - of which CD5024 is the first listed.
NCT01494467 names 20 study sites across 10 states, led by California, Alabama, Florida.
Frequently Asked Questions
What is clinical trial NCT01494467 about?
NCT01494467 is a clinical study titled "Phase 3 Papulopustular Rosacea Study". The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.
What is the current status of trial NCT01494467?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 688 participants. The study started on 2011-12. Estimated completion is 2013-08.
What conditions does trial NCT01494467 study?
This clinical trial studies the following conditions: Papulopustular Rosacea.
What interventions are being tested in trial NCT01494467?
The interventions under investigation include: CD5024 (DRUG), Azelaic acid 15% Gel (DRUG).
Who is sponsoring clinical trial NCT01494467?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01494467 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01494467's enrollment target sits among peer trials
688 2nd of 11 the highest of 11 other Papulopustular Rosacea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Papulopustular Rosacea 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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