Abstract |
The sap of the plant Euphorbia peplus is a traditional remedy for skin conditions, including actinic keratosis. The active constituent of the sap is ingenol mebutate (ingenol-3-angelate), formerly known as PEP005. This randomized, double-blind, vehicle-controlled, phase IIa study investigated the safety (and secondarily the efficacy) of two applications of ingenol mebutate gel in 58 patients with biopsy-confirmed actinic keratosis. Five preselected lesions were treated with ingenol mebutate gel, 0.0025%, 0.01% or 0.05%, or vehicle gel, on days 1 and 2 (Arm A) or days 1 and 8 (Arm B). There were no significant differences in tolerability or efficacy between Arms A and B. Treatment was well tolerated. The most common local skin responses were dose-related erythema, flaking/scaling/dryness and scabbing/crusting. Efficacy was greatest with ingenol mebutate gel, 0.05%, which resulted in complete clinical clearance of 71% of treated lesions (P < 0.0001 vs vehicle gel). In addition, 67% of patients treated with ingenol mebutate gel, 0.05% had clinical clearance of at least four of five treated lesions (P = 0.0185 vs vehicle gel). Ingenol mebutate gel is being developed as a short-course topical therapy for actinic keratosis and non- melanoma skin cancer.
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Authors | Greg Siller, Kurt Gebauer, Peter Welburn, Janelle Katsamas, Steven M Ogbourne |
Journal | The Australasian journal of dermatology
(Australas J Dermatol)
Vol. 50
Issue 1
Pg. 16-22
(Feb 2009)
ISSN: 1440-0960 [Electronic] Australia |
PMID | 19178487
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- 3-ingenyl angelate
- Antineoplastic Agents, Phytogenic
- Diterpenes
- Esters
- Gels
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Topics |
- Administration, Cutaneous
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents, Phytogenic
(therapeutic use)
- Arm
(pathology)
- Australia
- Diterpenes
(therapeutic use)
- Double-Blind Method
- Drug Administration Schedule
- Esters
(therapeutic use)
- Face
(pathology)
- Female
- Gels
(therapeutic use)
- Humans
- Keratosis, Actinic
(drug therapy, pathology)
- Male
- Middle Aged
- Scalp
(pathology)
- Treatment Outcome
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