Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1% to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product labeling for three weeks.

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Detailed Description

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Conditions

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Skin Manifestations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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metronidazole 1% gel

Group Type ACTIVE_COMPARATOR

metronidazole 1% gel

Intervention Type DRUG

Apply topically on one side of the face once daily for three weeks

azelaic acid 15% gel

Group Type ACTIVE_COMPARATOR

azelaic acid 15% gel

Intervention Type DRUG

Apply topically on the opposite side of the face twice daily for three weeks

Interventions

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metronidazole 1% gel

Apply topically on one side of the face once daily for three weeks

Intervention Type DRUG

azelaic acid 15% gel

Apply topically on the opposite side of the face twice daily for three weeks

Intervention Type DRUG

Other Intervention Names

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MetroGel® 1% Finacea® 15% Gel

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female adults (ages 18 years or older)
* Subjects with healthy skin as determined by the clinical grader

Exclusion Criteria

* Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions
* Subjects with known allergy to one of the components of the study drugs (refer to the package inserts for MetroGel® 1% and Finacea® Gel 15%)
* Subjects who have participated in another investigational drug or device research study within 30 days of enrollment
* Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids
* Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids
* Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the area to be treated
* Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes