Study of 0444 Gel in the Treatment of Inflammatory Lesions of Rosacea

Fougera Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Inflammatory Rosacea

Treatments: Drug: 0444

Study type: Interventional

Funder types: Industry

Identifiers

NCT01016782

0444

Details and patient eligibility

About

The aim of this trial is to assess the efficacy of Metronidazole Topical Gel 1% in the Treatment of Inflammatory Lesions of Rosacea.

Treatment medication will be administered as follows: A thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days.

Enrollment: 867 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of rosacea
• Good health with the exception of rosacea
• Papsules and pustules minimum and maximum requirements

Exclusion criteria

• Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
• Subjects who have any systemic or dermatological disorders with the exception of rosacea

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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867 participants in 3 patient groups, including a placebo group

Test

Experimental group

Description:

Test product that contains active pharmaceutical ingredient

Treatment:

Drug: 0444

Reference

Active Comparator group

Description:

Reference product that contains active pharmaceutical ingredient

Treatment:

Drug: 0444

Vehicle

Placebo Comparator group

Description:

Placebo that contains no active pharmaceutical ingredient

Treatment:

Drug: 0444