Status:

COMPLETED

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

Lead Sponsor:

Galderma R&D

Conditions:

Skin Manifestations

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.)

Key Trial Info

Start Date :

June 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2010

Estimated Enrollment :

77 Patients enrolled

Trial Details

Trial ID

NCT01139047

Start Date

June 1 2010

End Date

June 1 2010

Last Update

August 1 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Thomas J. Stephens & Associates, Inc.

Colorado Springs, Colorado, United States, 80915

Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin | DecenTrialz