CompletedPhase 3

A Therapeutic Equivalence Study of Two Metronidazole Gel 1% Topical Treatments of Rosacea

United States963 participantsStarted 2015-02

Plain-language summary

The purpose of this study is to compare the efficacy of two Metronidazole Gels 1%, in the treatment of Rosacea.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Male or Female subjects with at least 18 years of age; * Read and signed ICF; * Clinical Diagnosis of Rosacea; Exclusion Criteria: * Females who are pregnant, lactating or of childbearing potential who are not using or do not agree to use an acceptable form of contraception; * Any skin condition that would interfere with treatment of rosacea * Use of prohibited medications

What they're measuring

To compare the test and reference products of metronidazole topical gel 1% with regard to the mean percent change from Baseline of the inflammatory lesion counts of rosacea.

Timeframe: 70 Days

Trial details

NCT IDNCT02393937

SponsorbioRASI, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-07

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