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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
NCT01446237 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01446237
The ClinicalTrials.gov registry entry for NCT01446237 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stiefel, a GSK Company, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01446237 reports 9 study locations spanning 8 distinct geographic areas — top geographies include New Jersey, California, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01446237?
The interventions under investigation include: acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5% (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01446237?
This trial is sponsored by Stiefel, a GSK Company, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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