One-week treatment with once-daily fluorouracil cream 0.5% in participants with actinic keratoses.
ABSTRACT Actinic keratoses (AKs) are common in fair-skinned individuals with a history of chronic and excessive sun exposure and may progress to squamous cell carcinoma (SCC). Topical fluorouracil is an effective therapeutic option for patients with AKs, but it is associated with substantial skin irritation. The efficacy and tolerability of 1-week treatment using microsponge-based fluorouracil cream 0.5% were analyzed in 356 participants with AK lesions. One-week treatment with once-daily fluorouracil cream 0.5% was significantly more effective than vehicle control in reducing AK lesions and in achieving complete clearance (P<.001). No serious treatment-related adverse events occurred. The most frequent treatment-related adverse events were facial and eye irritations, which were predominantly mild to moderate in severity. No participants in the fluorouracil cream 0.5% treatment group discontinued the study because of treatment-related adverse events. One-week treatment with once-daily fluorouracil cream 0.5% is an effective well-tolerated therapy for AKs. Using this short treatment duration period in combination with cryosurgery may prove beneficial in clinical practice. Extending treatment for up to 4 weeks will further improve AK lesion clearance rates.
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ABSTRACT: Background. Oxybenzone, a broad spectrum sunscreen agent widely used in the form of lotion and cream, has been reported to cause skin irritation, dermatitis, and systemic absorption. Aim. The objective of the present study was to formulate oxybenzone loaded microsponge gel for enhanced sun protection factor with reduced toxicity. Material and Method. Microsponge for topical delivery of oxybenzone was successfully prepared by quasiemulsion solvent diffusion method. The effects of ethyl cellulose and dichloromethane were optimized by the 32 factorial design. The optimized microsponges were dispersed into the hydrogel and further evaluated. Results. The microsponges were spherical with pore size in the range of 0.10-0.22 µm. The optimized formulation possesses the particle size and entrapment efficiency of 72 ± 0.77 µm and 96.9 ± 0.52%, respectively. The microsponge gel showed the controlled release and was nonirritant to the rat skin. In creep recovery test it had shown highest recovery indicating elasticity. The controlled release of oxybenzone from microsponge and barrier effect of gel result in prolonged retention of oxybenzone with reduced permeation activity. Conclusion. Evaluation study revealed remarkable and enhanced topical retention of oxybenzone for prolonged period of time. It also showed the enhanced sun protection factor compared to the marketed preparation with reduced irritation and toxicity.01/2015; 2015:1-9. DOI:10.1155/2015/261068
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ABSTRACT: Abstract Skin is the largest organ of the human body and plays the most important role in protecting against pathogen and foreign matter. Three important modes such as topical, regional and transdermal are widely used for delivery of various dosage forms. Among these modes, the topical dosage forms are preferred because it provides local therapeutic activity when applied to the skin or mucous membranes. Additives or pharmaceutical excipients (non-drug component of dosage form) are used as inactive ingredients in dosage form or tools for structuring dosage forms. The main use of topical dosage form additives are controling the extent of absorption, maintaining the viscosity, improving the stability as well as organoleptic property and increasing the bulk of the formulation. The overall goal of this article is to provide the clinician with information related to the topical dosage form additives and their current major applications against various diseases.Drug Delivery 01/2014; DOI:10.3109/10717544.2013.879355 · 2.20 Impact Factor
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ABSTRACT: Actinic keratoses are common in older individuals and topical immunotherapy is an important treatment when multiple lesions are present. To assess the efficacy of 5-fluorouracil in treating actinic keratoses, a systematic review of randomized, vehicle-controlled trials was performed. Percentages of 5-fluorouracil and vehicle responders were determined by absolute clearance and mean percent reduction in lesion count. Four trials with 399 and 269 participants in active treatment and vehicle groups, respectively, were evaluated. After 4 weeks of treatment, total clearance and mean lesion count reduction were 52.6 and 90.2% in the treatment group versus 0.85 and 28.3% in the vehicle group, respectively. Topical 5-fluorouracil is efficacious in treating actinic keratoses; however, vehicle responses warrant further investigation of study design and disease severity scales.Immunotherapy 09/2012; 4(9):939-45. DOI:10.2217/imt.12.93 · 2.39 Impact Factor