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
1 other identifier
interventional
963
1 country
27
Brief Summary
The purpose of this study is to compare the efficacy of two Metronidazole Gels 1%, in the treatment of Rosacea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2015
Shorter than P25 for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 12, 2015
CompletedFirst Posted
Study publicly available on registry
March 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedSeptember 3, 2020
November 1, 2016
5 months
March 12, 2015
August 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (3)
Test: Metronidazole Gel 1%
EXPERIMENTALMetronidazole Gel 1% once daily for 70 days.
Reference: Metronidazole Gel 1%
ACTIVE COMPARATORMetronidazole Gel, 1% (MetroGel) Galderma S.A. once daily for 70 days.
Placebo
PLACEBO COMPARATORPlacebo Gel once daily for 70 days.
Interventions
Participants are assigned to one of three groups in parallel for the duration of the study
Participants are assigned to one of three groups in parallel for the duration of the study
Participants are assigned to one of three groups in parallel for the duration of the study
Eligibility Criteria
You may qualify if:
- Male or Female subjects with at least 18 years of age;
- Read and signed ICF;
- Clinical Diagnosis of Rosacea;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- bioRASI, LLClead
Study Sites (27)
Unknown Facility
Los Angeles, California, 90036, United States
Unknown Facility
San Diego, California, 92121, United States
Unknown Facility
Boca Raton, Florida, 33486, United States
Unknown Facility
Clearwater, Florida, 33761, United States
Unknown Facility
Miami, Florida, 33126, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Miramar, Florida, 33027q, United States
Unknown Facility
Ocala, Florida, 34471, United States
Unknown Facility
Tampa, Florida, 33634, United States
Unknown Facility
Lexington, Kentucky, 40509, United States
Unknown Facility
Watertown, Massachusetts, 02472, United States
Unknown Facility
Las Vegas, Nevada, 89104, United States
Unknown Facility
New York, New York, 10075, United States
Unknown Facility
High Point, North Carolina, 27262, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Cincinnati, Ohio, 45246, United States
Unknown Facility
Philadelphia, Pennsylvania, 19103, United States
Unknown Facility
Warwick, Rhode Island, 02886, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Austin, Texas, 78759, United States
Unknown Facility
El Paso, Texas, 79902, United States
Unknown Facility
Houston, Texas, 77055, United States
Unknown Facility
Pflugerville, Texas, 78660, United States
Unknown Facility
Plano, Texas, 75093, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Arlington, Virginia, 22203, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2015
First Posted
March 20, 2015
Study Start
February 1, 2015
Primary Completion
July 1, 2015
Study Completion
October 1, 2015
Last Updated
September 3, 2020
Record last verified: 2016-11