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

Taro Pharmaceuticals USA1 site in 1 country602 target enrollmentAugust 2011

ConditionsRosacea

InterventionsMetronidazole Topical Gel 1% (Metrogel)Metronidazole Topical Gel 1%Placebo

DrugsMetronidazole Topical Gel 1%Metronidazole Topical Gel 1% (Metrogel)Placebo

Overview

Phase: Phase 1
Intervention: Metronidazole Topical Gel 1% (Metrogel)
Conditions: Rosacea
Sponsor: Taro Pharmaceuticals USA
Enrollment: 602
Locations: 1
Primary Endpoint: Clinical Success
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

September 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Taro Pharmaceuticals USA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Arms & Interventions

Metronidazole Topical Gel 1% (Metrogel )

Intervention: Metronidazole Topical Gel 1% (Metrogel)

Metronidazole Topical Gel 1%

Intervention: Metronidazole Topical Gel 1%

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Clinical Success

Time Frame: Day 70

A patient is considered a clinical success if the IGE is 0 (Clear)or 1 (Almost Clear)

Treatment Success

Time Frame: Day 70

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