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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02393937
Enrollment
963
Registered
2015-03-20
Start date
2015-02-28
Completion date
2015-10-31
Last updated
2020-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erythematotelangiectatic Rosacea, Papulopustular Rosacea

Brief summary

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

Interventions

DRUGReference: Metronidazole Gel 1%

Participants are assigned to one of three groups in parallel for the duration of the study

DRUGTest: Metronidazole Gel 1%

Participants are assigned to one of three groups in parallel for the duration of the study

DRUGPlacebo Gel

Participants are assigned to one of three groups in parallel for the duration of the study

Sponsors

bioRASI, LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
To compare the test and reference product of metronidazole topical gel 1% with regard to the Investigator's Global Evaluation (IGE) of disease severity70 Days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026