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

Biorasi

Status and phase: Completed; Phase 3

Conditions: Erythematotelangiectatic Rosacea; Papulopustular Rosacea

Treatments: Drug: Test: Metronidazole Gel 1%; Drug: Placebo Gel; Drug: Reference: Metronidazole Gel 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02393937

LO-17-3-2014

Details and patient eligibility

About

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

Enrollment: 963 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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963 participants in 3 patient groups, including a placebo group

Test: Metronidazole Gel 1%

Experimental group

Description:

Metronidazole Gel 1% once daily for 70 days.

Treatment:

Drug: Test: Metronidazole Gel 1%

Reference: Metronidazole Gel 1%

Active Comparator group

Description:

Metronidazole Gel, 1% (MetroGel) Galderma S.A. once daily for 70 days.

Treatment:

Drug: Reference: Metronidazole Gel 1%

Placebo

Placebo Comparator group

Description:

Placebo Gel once daily for 70 days.

Treatment:

Drug: Placebo Gel