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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

602 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Metronidazole Topical Gel 1%

Group Type EXPERIMENTAL

Metronidazole Topical Gel 1%

Intervention Type DRUG

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

Metronidazole Topical Gel 1% (Metrogel )

Group Type ACTIVE_COMPARATOR

Metronidazole Topical Gel 1% (Metrogel)

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo applied to affected area once a day for 70 days

Interventions

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Metronidazole Topical Gel 1%

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

Intervention Type DRUG

Metronidazole Topical Gel 1% (Metrogel)

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

Intervention Type DRUG

Placebo

Placebo applied to affected area once a day for 70 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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MTZG 1101

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Metronidazole Topical Gel 1%

Metronidazole Topical Gel 1%

Metronidazole Topical Gel 1% (Metrogel )

Metronidazole Topical Gel 1% (Metrogel)

Placebo

Placebo

Interventions

Metronidazole Topical Gel 1%

Metronidazole Topical Gel 1% (Metrogel)

Placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Sun Pharmaceutical Industries, Inc.

Responsible Party

Locations

Investigator Site

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Countries

Other Identifiers

MTZG 1101