| A look at the safety of metronidazole 1% gel: cumulative irritation, contact sensitization, phototoxicity, and photoallergy potential. | |
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MedLine Citation:
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PMID: 16706245 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Karl R Beutner; Shawna Lemke; Barry Calvarese |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Cutis; cutaneous medicine for the practitioner Volume: 77 ISSN: 0011-4162 ISO Abbreviation: Cutis Publication Date: 2006 Apr |
Date Detail:
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Created Date: 2006-05-18 Completed Date: 2006-06-05 Revised Date: 2009-11-11 |
Medline Journal Info:
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Nlm Unique ID: 0006440 Medline TA: Cutis Country: United States |
Other Details:
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Languages: eng Pagination: 12-7 Citation Subset: IM |
Affiliation:
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Solano Clinical Research, Dow Pharmaceutical Sciences, Petaluma, California, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Dermatitis, Contact
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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:
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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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