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

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.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: Metronidazole Topical Gel 1%; Drug: Metronidazole Topical Gel 1% (Metrogel); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 602
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States
      • Investigator site
  • California
    • Long Beach, California, United States
      • Investigator site
    • Newport Beach, California, United States
      • Investigator site
  • Colorado
    • Denver, Colorado, United States
      • Investigator site
  • Florida
    • Jacksonville, Florida, United States
      • Investigator site
    • Miami, Florida, United States
      • Investigator site
    • Miramar, Florida, United States
      • Investigator site
  • Illinois
    • Arlington Heights, Illinois, United States
      • Investigator site
  • Indiana
    • Plainfield, Indiana, United States
      • Investigator site
  • Nevada
    • Henderson, Nevada, United States
      • Investigator site
  • North Carolina
    • Hickory, North Carolina, United States
      • Investigator site
    • High Point, North Carolina, United States
      • Investigator site
    • Wilmington, North Carolina, United States
      • Investigator site
  • Ohio
    • South Euclid, Ohio, United States
      • Investigator site
  • Pennsylvania
    • Hazelton, Pennsylvania, United States
      • Investigator site
  • South Carolina
    • Simpsonville, South Carolina, United States
      • Investigator site
  • Tennessee
    • Kingsport, Tennessee, United States
      • Investigator site
    • Knoxville, Tennessee, United States
      • Investigator site
    • Nashville, Tennessee, United States
      • Investigator site
  • Texas
    • San Antonio, Texas, United States
      • Investigator site
    • Webster, Texas, United States
      • Investigator site
  • Utah
    • West Jordan, Utah, United States
      • Investigator site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female, 18 years of age or older.
2. Signed informed consent form, which meets all criteria of current FDA regulations.
3. 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).
4. Have moderate to severe facial rosacea.
5. Have a Baseline Investigator Global Evaluation Score of 3 or 4.

Exclusion Criteria:

1. Mild facial rosacea (less than 8 inflammatory lesions on the face) or very severe rosacea (more than 50 inflammatory lesions)
2. Patients with excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with the diagnosis or assessment of rosacea.
3. History of hypersensitivity or allergy to Metronidazole, or other ingredients of the formulation.
4. 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.

5. 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
6. The use of anticoagulant therapy within 14 days prior to baseline.
7. The use of any antipruritics, including antihistamines within 24 hours of any study visits.
8. History of blood dyscrasia.
9. Ocular rosacea (e.g., conjunctivitis, blepharitis, keratitis) of sufficient severity to require topical or systemic antibiotics.
10. 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).
11. Females who are pregnant, lactating or likely to become pregnant during the study.
12. 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.
13. Any Patient (male or female) who has started, or changed hormonal therapy within 3 months of the Baseline visit (this includes hormonal contraceptives).
14. Use of high strength (20% or above) alpha-hydroxy acid for facial peel or any type of chemical facial skin peel or other significant cosmetic procedures within 2 months of the study start.
15. Receipt of any drug as part of a research study within 30 days prior to dosing.
16. Employees of the research center or Investigator.
17. Previous participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo applied to affected area once a day for 70 days
Experimental: Metronidazole Topical Gel 1%	Drug: Metronidazole Topical Gel 1%; Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
Active Comparator: Metronidazole Topical Gel 1% (Metrogel )	Drug: Metronidazole Topical Gel 1% (Metrogel); Metronidazole Topical Gel 1% applied to affected area once a day for 70 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Investigational Global Evaluation (IGE)	Mean change from baseline to end of treatment in IGE	Day 70

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: January 16, 2012
• First Submitted That Met QC Criteria: January 19, 2012
• First Posted (Estimate): January 20, 2012

Study Record Updates

• Last Update Posted (Estimate): December 23, 2013
• Last Update Submitted That Met QC Criteria: December 19, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: MTZG 1101