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NCT01951417 · ClinicalTrials.gov registry record · Phase 4
Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris
A Phase 4 study of Acne, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 4
- Development phase
- 81
- Enrollment target
- 5
- Study locations
NCT01951417: Completed Phase 4 study of Acne, sponsored by Galderma R&D.
NCT01951417 is a Phase 4 study of Acne that has completed, run by Galderma R&D. The registered enrollment target is 81 participants, below the 139-participant average among 26 other Acne trials with a reported enrollment target (42% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01951417, a Phase 4 study of Acne, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 81 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is an open-label, multi-center study to be conducted in the United States. The study will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30 (once daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible for treatment with Epiduo® in accordance with the currently approved product labeling and who meet other inclusion/exclusion criteria are to be enrolled in the study and receive the study products for 8 weeks. Efficacy and safety assessments include: complete lesion counts, cutaneous irritation assessment, end of study treatment questionnaire, photographic evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function assessment, treatment compliance, and adverse event assessment.
Primary Outcome
The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.
Conditions Studied
Interventions
- DRUG Adapalene/BPO Gel
- OTHER Moisturizer SPF 30
- OTHER Foam Wash
Study Locations (5)
Texas
- Stephens & Associates - Carrollton
- J&S Studies, Inc. - College Station
- The Dermatology Clinical Research Center of San Antonio - San Antonio
Florida
- Study Protocol, Inc. - Boynton Beach
Tennessee
- Tennessee Clinical Research Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
What the finished NCT01951417 record still lists
NCT01951417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 139-participant average among 26 other Acne trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Acne appearing as the primary indexed condition, and to 3 interventions - of which Adapalene/BPO Gel is the first listed.
NCT01951417 lists 5 locations in 3 states (Texas, Florida, Tennessee).
Frequently Asked Questions
What is clinical trial NCT01951417 about?
NCT01951417 is a clinical study titled "Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris". This is an open-label, multi-center study to be conducted in the United States. The study will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30 (once daily). Subjects with a c...
What is the current status of trial NCT01951417?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 81 participants. The study started on 2013-10. Estimated completion is 2014-03.
What conditions does trial NCT01951417 study?
This clinical trial studies the following conditions: Acne.
What interventions are being tested in trial NCT01951417?
The interventions under investigation include: Adapalene/BPO Gel (DRUG), Moisturizer SPF 30 (OTHER), Foam Wash (OTHER).
Who is sponsoring clinical trial NCT01951417?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01951417 being conducted?
This trial has 5 study locations across Florida, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01951417's enrollment target sits among peer trials
81 12th of 26 higher than 15 of 26 other Acne trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acne 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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