A Therapeutic Equivalence Study of Two Metronidazole 1%Topical Gel Treatments for Patients With Rosacea
MTZG
A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multi-Site Clinical Study to Compare the Bioequivalence of Two Metronidazole 1% Topical Gel Formulations in Patients With Moderate to Severe Rosacea
1 other identifier
interventional
602
1 country
22
Brief Summary
The objective of this study is to demonstrate that metronidazole 1% topical gel is effective for the treatment of patients with moderate to severe rosacea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2011
22 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
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 16, 2012
CompletedFirst Posted
Study publicly available on registry
January 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedDecember 23, 2013
December 1, 2013
10 months
January 16, 2012
December 19, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Clinical Success
A patient is considered a clinical success if the IGE is 0 (Clear)or 1 (Almost Clear)
Day 70
Treatment Success
A patient is considered a treatment success if the mean percent change from baseline at week 10 (Day 70) in the inflammatory (papules and pastales) lesion count of Rosacea
Day 70
Secondary Outcomes (1)
Change in Investigational Global Evaluation (IGE)
Day 70
Study Arms (3)
Metronidazole Topical Gel 1%
EXPERIMENTALMetronidazole Topical Gel 1% (Metrogel )
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
Eligibility Criteria
You may qualify if:
- Male or non-pregnant, non-lactating female, 18 years of age or older.
- Signed informed consent form, which meets all criteria of current FDA regulations.
- If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, transdermal, injected or implanted hormonal contraceptives).
- Have moderate to severe facial rosacea.
- Have a Baseline Investigator Global Evaluation Score of 3 or 4.
You may not qualify if:
- Mild facial rosacea (less than 8 inflammatory lesions on the face) or very severe rosacea (more than 50 inflammatory lesions)
- Patients with excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with the diagnosis or assessment of rosacea.
- History of hypersensitivity or allergy to Metronidazole, or other ingredients of the formulation.
- Use of oral retinoids (e.g. Accutane ®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) within the 6 months prior to the baseline visit.
- Use of the following within 1 month prior to the baseline visit:
- Topical Retinoids to the face
- Systemic antibiotics known to have an impact on the severity of facial Rosacea
- Systemic Steroids
- The use of anticoagulant therapy within 14 days prior to baseline.
- The use of any antipruritics, including antihistamines within 24 hours of any study visits.
- History of blood dyscrasia.
- Ocular rosacea (e.g., conjunctivitis, blepharitis, keratitis) of sufficient severity to require topical or systemic antibiotics.
- Any dermatological condition other than rosacea that in the Investigator's opinion may interfere with the evaluation of the Patient's rosacea (e.g., acne, psoriasis, dermatitis).
- Females who are pregnant, lactating or likely to become pregnant during the study.
- Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study Patient at undue risk by participation.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Investigator Site
Phoenix, Arizona, United States
Investigator Site
Long Beach, California, United States
Investigator Site
Newport Beach, California, United States
Investigator Site
Denver, Colorado, United States
Investigator Site
Jacksonville, Florida, United States
Investigator Site
Miami, Florida, United States
Investigator Site
Miramar, Florida, United States
Investigator Site
Arlington Heights, Illinois, United States
Investigator Site
Plainfield, Indiana, United States
Investigator Site
Henderson, Nevada, United States
Investigator Site
Hickory, North Carolina, United States
Investigator Site
High Point, North Carolina, United States
Investigator Site
Wilmington, North Carolina, United States
Investigator Site
South Euclid, Ohio, United States
Investigator Site
Hazleton, Pennsylvania, United States
Investigator Site
Simpsonville, South Carolina, United States
Investigator Site
Kingsport, Tennessee, United States
Investigator Site
Knoxville, Tennessee, United States
Investigator Site
Nashville, Tennessee, United States
Investigator Site
San Antonio, Texas, United States
Investigator Site
Webster, Texas, United States
Investigator Site
West Jordan, Utah, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2012
First Posted
January 20, 2012
Study Start
August 1, 2011
Primary Completion
June 1, 2012
Study Completion
September 1, 2012
Last Updated
December 23, 2013
Record last verified: 2013-12