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NCT01320033 · ClinicalTrials.gov registry record · Phase 2
Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris
A Phase 2 study of Acne Vulgaris, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 662
- Enrollment target
- 20
- Study locations
NCT01320033: Completed Phase 2 study of Acne Vulgaris, sponsored by Galderma R&D.
NCT01320033 is a Phase 2 study of Acne Vulgaris that has completed, run by Galderma R&D. The registered enrollment target is 662 participants, above the 265-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (150% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01320033, a Phase 2 study of Acne Vulgaris, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 662 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for 16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry Forward, Intent To Treat) in inflammatory lesion counts.
Primary Outcome
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CD2475/101 40 mg
- DRUG Doxycycline 100 mg
Study Locations (20)
Colorado
- Colorado Medical Research Center - Denver
- Longmont Medical Research Network - Longmont
Michigan
- Somerset Skin Care Center - Troy
- Grekin Skin Care - Warren
North Carolina
- Dermatology Consulting Services - High Point
- PMG Research of Wilmington - Wilmington
Arkansas
- Burke Pharmaceutical Research - Hot Springs
California
- Dermatology Research Associates, Inc. - Los Angeles
Florida
- International Dermatology Research, Inc. - Miami
Georgia
- MedaPhase, Inc. - Newnan
Kentucky
- Dermatology Specialists PC - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 662 participants |
| Start Date | 2011-03-29 |
| Est. Completion | 2012-01-03 |
| Phase | Phase 2 |
What the finished NCT01320033 record still lists
NCT01320033 is an interventional study that assigns participants to a tested intervention. The registered 662 participants enrollment target is mid-sized for trials with a published cap, above the 265-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (150% higher).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01320033 names 20 study sites across 17 states, led by Colorado, Michigan, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01320033 about?
NCT01320033 is a clinical study titled "Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris". The primary objectives of the study is to show CD2475/101 40mg tablets taken once a day for 16 weeks is superior to the placebo in Change from baseline to Week 16(Last Observation Carry Forward, Intent To Treat) in inflammatory lesion counts.
What is the current status of trial NCT01320033?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 662 participants. The study started on 2011-03-29. Estimated completion is 2012-01-03.
What conditions does trial NCT01320033 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT01320033?
The interventions under investigation include: Placebo (DRUG), CD2475/101 40 mg (DRUG), Doxycycline 100 mg (DRUG).
Who is sponsoring clinical trial NCT01320033?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01320033 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. 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 NCT01320033's enrollment target sits among peer trials
662 11th of 67 higher than 57 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults
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