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Showing posts from June 21, 2009

A look at the safety of metronidazole 1% gel

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 applicati...

A novel aqueous metronidazole 1% gel with hydrosolubilizing agents

Rosacea is a common chronic dermatosis that often is characterized by the presence of facial erythema, visible blood vessels, papules, and pustules. Because the face is the predominant site of involvement, rosacea may cause serious psychologic trauma and can significantly affect the quality of life of individuals with the condition. The first topical therapy approved for rosacea by the US Food and Drug Administration was metronidazole for the treatment of inflammatory lesions and erythema. A stable aqueous gel formulation of 1% metronidazole has been developed with the novel combination of hydrosolubilizing agents. Metronidazole 1% gel is a clear gel that exhibits advantageous qualities. Some features of the new product include being highly spreadable, easy to use, cosmetically friendly, ultramild, nondrying, and moisturizing. Data are presented from a 21-day cumulative irritation study, an assessment of skin barrier function, an in vitro skin penetration study, an absorption followi...

The effect of Cetaphil Gentle Skin Cleanser on the skin barrier of patients with rosacea

A good skin care regimen is a critical part of rosacea treatment ; however, care must be taken to choose nonirritating products because individuals with rosacea tend to have sensitive skin, and irritants can trigger a worsening of symptoms. This study examines the use of Cetaphil Gentle Skin Cleanser (a nonalkaline nonirritating cleanser) in patients with rosacea. To eliminate the confounding effects of various treatments, the cleanser was studied for a 2-week period in the absence of rosacea therapy following a 2-week washout period in patients with mild to moderate rosacea. During the washout period, patients were asked to cleanse twice daily with Dove Sensitive Skin Bar. During the 2-week study period, patients were monitored for skin barrier function through transepidermal water loss (TEWL) and corneometry; patients also were monitored for rosacea severity. Thirty patients were enrolled. No significant increase in TEWL was demonstrated at any point during the study, indicating t...

ATPgammaS enhances the production of inflammatory mediators

Adenosine 5'-triphosphate (ATP) affects multiple intra- and extracellular processes, including vascular tone and immune responses. Microvascular endothelial cells (EC) play a central role in inflammation by recruitment of inflammatory cells from blood to tissues. We hypothesized that ATP (secreted by neurons and/or released after perturbation of cutaneous cells) may influence secretion of inflammatory messengers by dermal microvascular EC through actions on purinergic P2 receptors. Addition of the hydrolysis-resistant ATP analogue, adenosine 5'-O-(3-thiotriphosphate) (ATPgammaS), to subconfluent cultures of the human microvascular endothelial cell-1 (HMEC-1) cell line led to a dose- and time-dependent increase in release of IL-6, IL-8, monocyte chemoattractant protein-1, and growth-regulated oncogene alpha. Both ATPgammaS-induced release and basal production of these proteins were significantly inhibited by the purinergic antagonists pyridoxal-5'-phosphate-6-azophenyl-2...