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

Papulopustular Rosacea Clinical Trial

Official title:

A Multi-center, Double-blind, Randomized, Vehicle-controlled, Parallel-group Study Comparing Metronidazole Gel 1%, to Metrogel® (Metronidazole Gel) 1% in the Treatment of Rosacea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393937
• Other study ID #: LO-17-3-2014
• Status: Completed
• Phase: Phase 3
• Start date: February 2015
• Est. completion date: October 2015

Study information

• Verified date: November 2016
• Source: bioRASI, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 963
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erythematotelangiectatic Rosacea
• Papulopustular Rosacea
• Rosacea

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
bioRASI, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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