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NCT01017120 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne
A Phase 3 study of Acne Vulgaris, sponsored by Stiefel, a GSK Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 742
- Enrollment target
- 18
- Study locations
NCT01017120: Completed Phase 3 study of Acne Vulgaris, sponsored by Stiefel, a GSK Company.
NCT01017120 is a Phase 3 study of Acne Vulgaris that has completed, run by Stiefel, a GSK Company. The registered enrollment target is 742 participants, above the 264-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (181% higher). The trial reports 18 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01017120, a Phase 3 study of Acne Vulgaris, has completed, sponsored by Stiefel, a GSK Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 742 participants
- Enrollment target
- 18
- Study locations
Study Summary
The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.
Primary Outcome
LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.
Conditions Studied
Interventions
- DRUG Vehicle Foam
- DRUG Tazarotene Foam
Study Locations (18)
Georgia
- Atlanta Dermatology & Vein Research Center, PC - Alpharetta
- Gwinnett Clinical Research Center, Inc. - Snellville
Michigan
- Henry Ford Medical Center - Detroit
- Somerset Skin Centre - Troy
Texas
- Suzanne Bruce and Associates, PA - Houston
- Progressive Clinical Research - San Antonio
Ontario
- Lynderm Research, Inc. - Markham
- North Bay Dermatology Centre - North Bay
California
- The Laser Institute for Dermatology - Santa Monica
Florida
- FXM Research Corporation - Miami
Indiana
- Hudson Dermatology - Evansville
Kentucky
- Dermatology Specialists - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 742 participants |
| Start Date | 2009-10-01 |
| Est. Completion | 2010-11-09 |
| Phase | Phase 3 |
What the finished NCT01017120 record still lists
NCT01017120 is an interventional study that assigns participants to a tested intervention. The registered 742 participants enrollment target is mid-sized for trials with a published cap, above the 264-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (181% higher).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 2 interventions - of which Vehicle Foam is the first listed.
NCT01017120 lists 18 locations in 14 states (Georgia, Michigan, Texas).
Frequently Asked Questions
What is clinical trial NCT01017120 about?
NCT01017120 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne". The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.
What is the current status of trial NCT01017120?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 742 participants. The study started on 2009-10-01. Estimated completion is 2010-11-09.
What conditions does trial NCT01017120 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT01017120?
The interventions under investigation include: Vehicle Foam (DRUG), Tazarotene Foam (DRUG).
Who is sponsoring clinical trial NCT01017120?
This trial is sponsored by Stiefel, a GSK Company, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01017120 being conducted?
This trial has 18 study locations across California, Florida, Georgia, Indiana, Kentucky. 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 NCT01017120's enrollment target sits among peer trials
742 9th of 67 higher than 59 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.
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