New actinic keratosis study findings have been published by L. Anderson and colleagues
2009 JUL 13 - (NewsRx.com) -- "There is a need for improved medical approaches to the treatment of actinic keratosis. Ingenol mebutate, a diterpene ester extracted and purified from the plant Euphorbia peplus, is being evaluated as a topical therapy for actinic keratosis," investigators in the United States report. "Assess the efficacy and safety of ingenol mebutate (formerly PEP005) gel at 3 closing regimens for the treatment of actinic keratosis. Patients with non-facial actinic keratoses applied vehicle gel for 3 days, ingenol mebutate gel, 0.025% for 3 days, or ingenol mebutate gel, 0.05% for 2 or 3 days, with an 8-week follow-tip period. All 3 active treatments were significantly more effective than vehicle at clearing actinic keratosis lesions, with a close response observed. The partial clearance rate (primary efficacy end point) for patients treated with ingenol mebutate gel ranged from 56.0% to 75.4% compared with 21.7% for vehicle gel (P = .0002 to P< .0001. vs vehicle). The complete clearance rate was also significantly higher (P <= .0006) for patients in the ingenol mebutate gel treatment groups (range: 40.0% to 54.4%) compared with vehicle (11.7%), as was the baseline clearance rate (range: 42.0% to 57.9% for ingenol mebutate gel compared with 13.3% for vehicle, P< .0001 to .0007 vs vehicle). The median percentage reduction in baseline actinic keratosis lesions for patients treated with ingenol mebutate gel ranged from 75% to 100% compared with 0% for vehicle gel (P < .0001 vs vehicle). Active treatment was well tolerated at all dosages. The mechanism of action of this agent is the localized induction of necrosis followed by a transient inflammatory response, and this was manifested in most patients as transient local skin responses consisting primarily of erythema, flaking/scaling, and crusting. There was no evidence of treatment-related scarring. Limitations: Local skin responses may have suggested active treatment to investigators," wrote L. Anderson and colleagues. The researchers concluded: "Short-course, field-directed therapy with ingenol mebutate gel for actinic keratoses on non-facial sites seems to be effective with a favorable safety profile and potential benefits over topical agents that require a more prolonged course of treatment. (J Am Acad Dermatol 2009;60:934-43.)." Anderson and colleagues published their study in the Journal of the American Academy of Dermatology (Randomized, double-blind, double-dummy, vehicle-controlled study of ingenol mebutate gel 0.025% and 0.05% for actinic keratosis. Journal of the American Academy of Dermatology, 2009;60(6):934-943). For additional information, contact L. Anderson, 1367 Domin Plaza, Tyler, TX 75703, USA. The publisher of the Journal of the American Academy of Dermatology can be contacted at: Mosby-Elsevier, 360 Park Avenue South, New York, NY 10010-1710, USA. Keywords: United States, Tyler, Actinic Keratosis, Clinical Trial Research, Dermatology, Therapy, Treatment. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.
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