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

Rosacea Clinical Trial

— MTZG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513863
• Other study ID #: MTZG 1101
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2012
• Last updated: December 19, 2013
• Start date: August 2011
• Est. completion date: September 2012

Study information

• Verified date: December 2013
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• Metronidazole Topical Gel 1%
Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
• Metronidazole Topical Gel 1% (Metrogel)
Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
• Placebo
Placebo applied to affected area once a day for 70 days

Locations

Country	Name	City	State
United States	Investigator Site	Arlington Heights	Illinois
United States	Investigator Site	Denver	Colorado
United States	Investigator Site	Hazelton	Pennsylvania
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	Jacksonville	Florida
United States	Investigator Site	Kingsport	Tennessee
United States	Investigator Site	Knoxville	Tennessee
United States	Investigator Site	Long Beach	California
United States	Investigator Site	Miami	Florida
United States	Investigator Site	Miramar	Florida
United States	Investigator Site	Nashville	Tennessee
United States	Investigator Site	Newport Beach	California
United States	Investigator Site	Phoenix	Arizona
United States	Investigator Site	Plainfield	Indiana
United States	Investigator Site	San Antonio	Texas
United States	Investigator Site	Simpsonville	South Carolina
United States	Investigator Site	South Euclid	Ohio
United States	Investigator Site	Webster	Texas
United States	Investigator Site	West Jordan	Utah
United States	Investigator Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success	A patient is considered a clinical success if the IGE is 0 (Clear)or 1 (Almost Clear)	Day 70	No
Primary	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	No
Secondary	Change in Investigational Global Evaluation (IGE)	Mean change from baseline to end of treatment in IGE	Day 70	No