Copenhagen, Denmark (ots/PRNewswire) – - NOT INTENDED FOR US MEDIA
- Ingenol Mebutate is an Investigational Two-to-Three Day Topical Treatment for Precancerous Skin Disease
Clinical data from four Phase 3 studies of ingenol mebutate gel, an investigational treatment for actinic keratosis, were presented publicly for the first time at the 22nd World Congress of Dermatology in Seoul. Two of the studies evaluated the efficacy and safety of ingenol mebutate 0.05% applied once daily for two consecutive days to actinic keratoses (multiple lesions) on the body. The other two studies evaluated the efficacy and safety of ingenol mebutate 0.015% applied once daily for three consecutive days to actinic keratoses on the face and scalp. The primary endpoint for all four studies was complete clearance rate of actinic keratoses at the day 57 visit.
(Logo: http://www.newscom.com/cgi-bin/prnh/20110606/460992 )
Actinic keratosis, caused by long-term UV exposure, is a precancerous skin condition, which can lead to squamous cell carcinoma, a non-melanoma form of skin cancer. “Since there is no way to predict which actinic keratoses will advance to skin cancer, early detection and treatment of lesions is critical,” said Mark Lebwohl, M.D., Professor and Chair, Department of Dermatology, Mount Sinai Medical Center in New York.
Face and Scalp Data
Two of the studies compared ingenol mebutate 0.015% to a placebo (vehicle) applied once daily for three consecutive days to actinic keratoses on the face or scalp. In the first study, after 57 days (about 8 weeks), complete clearance of actinic keratosis lesions occurred in 47% (67/142) of patients using ingenol mebutate and 5% (7/136) of patients using placebo (P
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