Results   : The results of this study showed that PEP005 (ingenol mebutate)  treatment had a favorable safety profile, with absence of systemic toxicity. Erythema, scaling and scabbing were the most common local skin responses occurring in patients treated with PEP005 (ingenol mebutate) Gel. All local skin responses were reported as mild. These results indicate that topical application of PEP005 (ingenol mebutate) Gel   is well-tolerated, with the predominant toxicity being mild but manageable erythema when the gel was applied to AK lesions.

Efficacy was also evaluated and showed that topical application of PEP005 (ingenol mebutate) Gel was associated with AK lesion clearance activity. Of the four PEP005 (ingenol mebutate) Gel-treated patients with day 21 follow up, complete clearance of all five AK lesions was observed in one patient and complete clearance of four out of five lesions was reported in a second patient. The trial demonstrated positive indications of the product's ability to clear lesions with 40% of treated lesions either completely cleared or almost cleared compared with the vehicle control of 15%. These results supported the start of phase IIa clinical trials.

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