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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01951417
The ClinicalTrials.gov registry entry for NCT01951417 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 139-participant average among 26 other Acne trials with a reported enrollment target (42% lower). The listed sponsor is Galderma R&D, which has 158 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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