Clinical trial NCT02393937: A Therapeutic Equivalence Study of Two Metronidazole Gel 1% Topical Treatments of Rosacea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Papulopustular Rosacea
Erythematotelangiectatic Rosacea
Lead sponsor: bioRASI, LLC
Sponsor class: INDUSTRY
First posted: 2015-03-20
Enrollment: 963
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 70 Days
Secondary outcomes:
measure: To compare the test and reference product of metronidazole topical gel 1% with regard to the Investigator's Global Evaluation (IGE) of disease severity
timeFrame: 70 Days
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Boca Raton
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miramar
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Lexington
country: United States
state: Kentucky
city: Watertown
country: United States
state: Massachusetts
city: Las Vegas
country: United States
state: Nevada
city: New York
country: United States
state: New York
city: High Point
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Mount Pleasant
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Pflugerville
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Arlington
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
Study officials:
References: