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NCT01446237 · ClinicalTrials.gov registry record · NA
U0289-405: An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects With Acne
A NA study of Acne Vulgaris, sponsored by Stiefel, a GSK Company.
- Completed
- Registry status
- NA
- Development phase
- 125
- Enrollment target
- 9
- Study locations
NCT01446237: Completed NA study of Acne Vulgaris, sponsored by Stiefel, a GSK Company.
NCT01446237 is a NA study of Acne Vulgaris that has completed, run by Stiefel, a GSK Company. The registered enrollment target is 125 participants, below the 274-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (54% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01446237, a NA study of Acne Vulgaris, has completed, sponsored by Stiefel, a GSK Company.
- COMPLETED
- Registry status
- NA
- Development phase
- 125 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study is being conducted to obtain safety, efficacy, and satisfaction data on the combination of topical Benzoyl Peroxide (BPO) 2.5% and the topical keratolytic agent Salicylic Acid (SA) 0.5% in the treatment of moderate to severe acne. Subjects with moderate or severe acne will be asked to apply the commercially available, over-the-counter products Foam Deep Cleanser (2.5% BPO), Foam Advanced Acne Treatment (2.5% BPO), and Foam Rejuvenating Toner (0.5% SA) daily for 12 weeks. No control group or reference treatment will be included.
Primary Outcome
The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extended from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline i
Conditions Studied
Interventions
- OTHER acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%
Study Locations (9)
New Jersey
- GSK Investigational Site - Belleville
- GSK Investigational Site - Montclair
California
- GSK Investigational Site - Fremont
Kentucky
- GSK Investigational Site - Louisville
Maryland
- GSK Investigational Site - Rockville
New York
- GSK Investigational Site - Stony Brook
North Carolina
- GSK Investigational Site - High Point
Tennessee
- GSK Investigational Site - Knoxville
Texas
- GSK Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2011-06-01 |
| Est. Completion | 2011-12-15 |
| Phase | NA |
What the finished NCT01446237 record still lists
NCT01446237 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 274-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 1 intervention - of which acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5% is the first listed.
NCT01446237 lists 9 locations in 8 states (New Jersey, California, Kentucky).
Frequently Asked Questions
What is clinical trial NCT01446237 about?
NCT01446237 is a clinical study titled "U0289-405: An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects With Acne". This study is being conducted to obtain safety, efficacy, and satisfaction data on the combination of topical Benzoyl Peroxide (BPO) 2.5% and the topical keratolytic agent Salicylic Acid (SA) 0.5% in the treatment of moderate to severe acne. Subjects with moderate or severe acne will be asked to app...
What is the current status of trial NCT01446237?
This trial is currently completed. It is a NA study. The enrollment target is 125 participants. The study started on 2011-06-01. Estimated completion is 2011-12-15.
What conditions does trial NCT01446237 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT01446237?
The interventions under investigation include: acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5% (OTHER).
Who is sponsoring clinical trial NCT01446237?
This trial is sponsored by Stiefel, a GSK Company, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01446237 being conducted?
This trial has 9 study locations across California, Kentucky, Maryland, New Jersey, New York. 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 NCT01446237's enrollment target sits among peer trials
125 35th of 67 higher than 33 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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