Document Detail


A look at the safety of metronidazole 1% gel: cumulative irritation, contact sensitization, phototoxicity, and photoallergy potential.
MedLine Citation:
PMID:  16706245     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Rosacea is a common, recurrent, inflammatory dermatologic disorder characterized by the presence of facial erythema, visible blood vessels, papules, and pustules. The condition may cause serious psychologic morbidity and may significantly affect quality of life. The first topical rosacea therapy approved by the US Food and Drug Administration was metronidazole for the treatment of inflammatory lesions and erythema. Previously, metronidazole was available as a 0.75% gel. Improved solubility was achieved in a new, stable, aqueous gel that permitted the formulation of metronidazole 1.0%. This new formulation is highly spreadable, easy to use, cosmetically friendly, mild to the skin, nondrying, and moisturizing. The safety of metronidazole 1% gel was determined by the evaluation of its cumulative irritation, contact sensitization, phototoxicity, and photoallergy potential in healthy male and female patients. In this formulation, metronidazole was not irritating under occlusive application. Additionally, metronidazole 1% gel had a low potential for causing sensitization reactions, and no evidence suggested phototoxic or photoallergic reactions.
Authors:
Karl R Beutner; Shawna Lemke; Barry Calvarese
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Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Cutis; cutaneous medicine for the practitioner     Volume:  77     ISSN:  0011-4162     ISO Abbreviation:  Cutis     Publication Date:  2006 Apr 
Date Detail:
Created Date:  2006-05-18     Completed Date:  2006-06-05     Revised Date:  2009-11-11    
Medline Journal Info:
Nlm Unique ID:  0006440     Medline TA:  Cutis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  12-7     Citation Subset:  IM    
Affiliation:
Solano Clinical Research, Dow Pharmaceutical Sciences, Petaluma, California, USA.
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MeSH Terms
Descriptor/Qualifier:
Dermatitis, Contact / etiology,  pathology
Dermatitis, Photoallergic / etiology,  pathology
Dermatitis, Phototoxic / etiology,  pathology
Dermatologic Agents / administration & dosage*,  adverse effects
Erythema / chemically induced,  pathology
Female
Gels
Humans
Male
Metronidazole / administration & dosage*,  adverse effects
Rosacea / drug therapy*,  pathology
Single-Blind Method
Chemical
Reg. No./Substance:
0/Dermatologic Agents; 0/Gels; 443-48-1/Metronidazole

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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