Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin
Summary
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.
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Conditions
Skin Manifestations
Intervention
metronidazole 1% gel, azelaic acid 15% gel
Location
Thomas J. Stephens and Associates, Inc.
Carrollton
Texas
United States
75006
Status
Completed
Source
Galderma Laboratories, L.P.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01139008
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Leprosy, Paucibacillary
A form of LEPROSY classified by the World Health Organization for the purpose of treatment, based on clinical manifestations and skin smear results. Patients with paucibacillary leprosy have fewer than six skin lesions with no causative agent MYCOBACTERIUM LEPRAE on any slit-skin smear testing. Paucibacillary leprosy encompasses indeterminate, borderline tuberculoid, and tuberculoid leprosy.
Skin Manifestations
Dermatologic disorders attendant upon non-dermatologic disease or injury.
Metronidazole
A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS. It has also been proposed as a radiation sensitizer for hypoxic cells. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985, p133), this substance may reasonably be anticipated to be a carcinogen (Merck, 11th ed).
Leprosy, Multibacillary
A form of LEPROSY classified by the World Health Organization for the purpose of treatment, based on clinical manifestations and skin smear results. Patients with multibacillary leprosy have six or more lesions with or without positive skin smear results for the causative agent MYCOBACTERIUM LEPRAE. Multibacillary leprosy encompasses borderline lepromatous, midborderline, and lepromatous leprosy.
Morgellons Disease
An unexplained illness which is characterized by skin manifestations including non-healing lesions, itching, and the appearance of fibers. There appears to be a strong association with LYME DISEASE.
Clinical Trials
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.
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This study is to determine whether a medication on the market for other indications is effective and safe in treating seborrheic dermatitis of the face.
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