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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01513863
First received: January 16, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Rosacea
Drug: Metronidazole Topical Gel 1%
Drug: Metronidazole Topical Gel 1% (Metrogel)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • Clinical Success [ Time Frame: Day 70 ] [ Designated as safety issue: No ]
    A patient is considered a clinical success if the IGE is 0 (Clear)or 1 (Almost Clear)

  • Treatment Success [ Time Frame: Day 70 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change in Investigational Global Evaluation (IGE) [ Time Frame: Day 70 ] [ Designated as safety issue: No ]
    Mean change from baseline to end of treatment in IGE


Enrollment: 602
Study Start Date: August 2011
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: Placebo
Placebo applied to affected area once a day for 70 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513863

Locations
United States, Arizona
Investigator Site
Phoenix, Arizona, United States
United States, California
Investigator Site
Long Beach, California, United States
Investigator Site
Newport Beach, California, United States
United States, Colorado
Investigator Site
Denver, Colorado, United States
United States, Florida
Investigator Site
Jacksonville, Florida, United States
Investigator Site
Miami, Florida, United States
Investigator Site
Miramar, Florida, United States
United States, Illinois
Investigator Site
Arlington Heights, Illinois, United States
United States, Indiana
Investigator Site
Plainfield, Indiana, United States
United States, Nevada
Investigator Site
Henderson, Nevada, United States
United States, North Carolina
Investigator Site
Hickory, North Carolina, United States
Investigator Site
High Point, North Carolina, United States
Investigator Site
Wilmington, North Carolina, United States
United States, Ohio
Investigator Site
South Euclid, Ohio, United States
United States, Pennsylvania
Investigator Site
Hazelton, Pennsylvania, United States
United States, South Carolina
Investigator Site
Simpsonville, South Carolina, United States
United States, Tennessee
Investigator Site
Kingsport, Tennessee, United States
Investigator Site
Knoxville, Tennessee, United States
Investigator Site
Nashville, Tennessee, United States
United States, Texas
Investigator Site
San Antonio, Texas, United States
Investigator Site
Webster, Texas, United States
United States, Utah
Investigator Site
West Jordan, Utah, United States
Sponsors and Collaborators
Taro Pharmaceuticals USA
  More Information

No publications provided

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01513863     History of Changes
Other Study ID Numbers: MTZG 1101
Study First Received: January 16, 2012
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Metronidazole
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014