A Therapeutic Equivalence Study of Two Metronidazole Gel... | NCT02393937 | Trialant

A Therapeutic Equivalence Study of Two Metronidazole Gel... | NCT02393937 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test: Metronidazole Gel 1%	Experimental	Metronidazole Gel 1% once daily for 70 days.	Drug: Test: Metronidazole Gel 1%
Reference: Metronidazole Gel 1%	Active Comparator	Metronidazole Gel, 1% (MetroGel) Galderma S.A. once daily for 70 days.	Drug: Reference: Metronidazole Gel 1%
Placebo	Placebo Comparator	Placebo Gel once daily for 70 days.	Drug: Placebo Gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reference: Metronidazole Gel 1%	Drug	Participants are assigned to one of three groups in parallel for the duration of the study	Reference: Metronidazole Gel 1%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		70 Days

Secondary Outcomes

Measure	Description	Time Frame
To compare the test and reference product of metronidazole topical gel 1% with regard to the Investigator's Global Evaluation (IGE) of disease severity		70 Days