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A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris
NCT02571998 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to evaluate the safety and efficacy of Omiganan (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjects with moderate to severe inflammatory acne vulgaris.
Conditions Studied
Interventions
- DRUG Vehicle Topical Gel
- DRUG Omiganan (CLS001) Topical Gel
Study Locations (20)
Florida
- — Boca Raton
- — Boynton Beach
- — Miami
- — Pinellas Park
- — Sanford
- — Tampa
California
- — Santa Ana
- — Santa Monica
New York
- — New York
- — Stony Brook
Alabama
- — Mobile
Arizona
- — Phoenix
Colorado
- — Denver
Massachusetts
- — Beverly
Michigan
- — Fort Gratiot
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2015-10 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02571998
The ClinicalTrials.gov registry entry for NCT02571998 describes a study currently listed as completed. It is categorized as Phase 2, 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 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Maruho Co., which has 3 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 2 interventions — of which Vehicle Topical Gel 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: NCT02571998 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, California, New York. 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 NCT02571998 about?
NCT02571998 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris". The primary objective of this study is to evaluate the safety and efficacy of Omiganan (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjects with moderate to severe inflammatory acne vulgaris.
What is the current status of trial NCT02571998?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2015-10. Estimated completion is 2016-08.
What conditions does trial NCT02571998 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 NCT02571998?
The interventions under investigation include: Vehicle Topical Gel (DRUG), Omiganan (CLS001) Topical Gel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02571998?
This trial is sponsored by Maruho Co., which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02571998 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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