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

• Sponsor: Taro Pharmaceuticals USA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01513863
• Collaborator: (none)
• Enrollment: 602
• Locations: 22
• Arms: 3
• Duration (Months): 13
• Patients Per Site: 27.4
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: Metronidazole Topical Gel 1%; Drug: Metronidazole Topical Gel 1% (Metrogel); Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 602 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, 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
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Clinical Success [Day 70]

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

2. Treatment Success [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

Secondary Outcome Measures

1. Change in Investigational Global Evaluation (IGE) [Day 70]

   Mean change from baseline to end of treatment in IGE

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. The use of anticoagulant therapy within 14 days prior to baseline.

2. The use of any antipruritics, including antihistamines within 24 hours of any study visits.

3. History of blood dyscrasia.

4. Ocular rosacea (e.g., conjunctivitis, blepharitis, keratitis) of sufficient severity to require topical or systemic antibiotics.

5. 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).

6. Females who are pregnant, lactating or likely to become pregnant during the study.

7. 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.

8. Any Patient (male or female) who has started, or changed hormonal therapy within 3 months of the Baseline visit (this includes hormonal contraceptives).

9. 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.

10. Receipt of any drug as part of a research study within 30 days prior to dosing.

11. Employees of the research center or Investigator.

12. Previous participation in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigator Site	Phoenix	Arizona	United States
2	Investigator Site	Long Beach	California	United States
3	Investigator Site	Newport Beach	California	United States
4	Investigator Site	Denver	Colorado	United States
5	Investigator Site	Jacksonville	Florida	United States
6	Investigator Site	Miami	Florida	United States
7	Investigator Site	Miramar	Florida	United States
8	Investigator Site	Arlington Heights	Illinois	United States
9	Investigator Site	Plainfield	Indiana	United States
10	Investigator Site	Henderson	Nevada	United States
11	Investigator Site	Hickory	North Carolina	United States
12	Investigator Site	High Point	North Carolina	United States
13	Investigator Site	Wilmington	North Carolina	United States
14	Investigator Site	South Euclid	Ohio	United States
15	Investigator Site	Hazelton	Pennsylvania	United States
16	Investigator Site	Simpsonville	South Carolina	United States
17	Investigator Site	Kingsport	Tennessee	United States
18	Investigator Site	Knoxville	Tennessee	United States
19	Investigator Site	Nashville	Tennessee	United States
20	Investigator Site	San Antonio	Texas	United States
21	Investigator Site	Webster	Texas	United States
22	Investigator Site	West Jordan	Utah	United States

Sponsors and Collaborators

• Taro Pharmaceuticals USA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taro Pharmaceuticals USA
• ClinicalTrials.gov Identifier: NCT01513863
• Other Study ID Numbers: MTZG 1101
• First Posted: Jan 20, 2012
• Last Update Posted: Dec 23, 2013
• Last Verified: Dec 1, 2013

• Additional relevant MeSH terms: Rosacea; Metronidazole

Study Results

No Results Posted as of Dec 23, 2013