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NCT01880320 · ClinicalTrials.gov registry record · Phase 3
Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris
A Phase 3 study, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 503
- Enrollment target
NCT01880320: Completed Phase 3 study, sponsored by Galderma R&D.
NCT01880320 is a Phase 3 study that has completed, run by Galderma R&D. The registered enrollment target is 503 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01880320, a Phase 3 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 503 participants
- Enrollment target
Study Summary
The study hypothesis are based on the assumption that : * CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects * CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile
Primary Outcome
Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.
Interventions
- DRUG Topical Gel Vehicle
- DRUG CD0271 0.3% / CD1579 2.5%
- DRUG CD0271 0.1% / CD1579 2.5%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 503 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
What the finished NCT01880320 record still lists
NCT01880320 is an interventional study that assigns participants to a tested intervention. The registered 503 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 3 interventions - of which Topical Gel Vehicle is the first listed.
NCT01880320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01880320 about?
NCT01880320 is a clinical study titled "Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris". The study hypothesis are based on the assumption that : * CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects * CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acc...
What is the current status of trial NCT01880320?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 503 participants. The study started on 2013-07. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01880320?
The interventions under investigation include: Topical Gel Vehicle (DRUG), CD0271 0.3% / CD1579 2.5% (DRUG), CD0271 0.1% / CD1579 2.5% (DRUG).
Who is sponsoring clinical trial NCT01880320?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01880320's enrollment target sits among peer trials
503 743rd of 2000 higher than 1,258 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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