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

NCT01513863 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2013-12-23

No results posted yet for this study

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.

Conditions

  • Rosacea

Interventions

DRUG

Metronidazole Topical Gel 1%

Metronidazole Topical Gel 1% applied to affected area once a day for 70 days

DRUG

Metronidazole Topical Gel 1% (Metrogel)

Metronidazole Topical Gel 1% applied to affected area once a day for 70 days

DRUG

Placebo

Placebo applied to affected area once a day for 70 days

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-06-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01513863 on ClinicalTrials.gov