A Therapeutic Equivalence Study of Two Metronidazole Gel 1% Topical Treatments of Rosacea
NCT ID: NCT02393937
Last Updated: 2020-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
963 participants
INTERVENTIONAL
2015-02-28
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test: Metronidazole Gel 1%
Metronidazole Gel 1% once daily for 70 days.
Test: Metronidazole Gel 1%
Participants are assigned to one of three groups in parallel for the duration of the study
Reference: Metronidazole Gel 1%
Metronidazole Gel, 1% (MetroGel) Galderma S.A. once daily for 70 days.
Reference: Metronidazole Gel 1%
Participants are assigned to one of three groups in parallel for the duration of the study
Placebo
Placebo Gel once daily for 70 days.
Placebo Gel
Participants are assigned to one of three groups in parallel for the duration of the study
Interventions
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Reference: Metronidazole Gel 1%
Participants are assigned to one of three groups in parallel for the duration of the study
Test: Metronidazole Gel 1%
Participants are assigned to one of three groups in parallel for the duration of the study
Placebo Gel
Participants are assigned to one of three groups in parallel for the duration of the study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Read and signed ICF;
* Clinical Diagnosis of Rosacea;
Exclusion Criteria
* Any skin condition that would interfere with treatment of rosacea
* Use of prohibited medications
18 Years
ALL
No
Sponsors
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bioRASI, LLC
INDUSTRY
Responsible Party
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Locations
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Los Angeles, California, United States
San Diego, California, United States
Boca Raton, Florida, United States
Clearwater, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miramar, Florida, United States
Ocala, Florida, United States
Tampa, Florida, United States
Lexington, Kentucky, United States
Watertown, Massachusetts, United States
Las Vegas, Nevada, United States
New York, New York, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Warwick, Rhode Island, United States
Mt. Pleasant, South Carolina, United States
Austin, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Pflugerville, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Arlington, Virginia, United States
Norfolk, Virginia, United States
Countries
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Other Identifiers
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LO-17-3-2014
Identifier Type: -
Identifier Source: org_study_id
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