PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: Results of a randomized phase IIa trial

Siller, Greg, Rosen, Robert, Freeman, Michael, Welburn, Peter, Katsamas, Janelle and Ogbourne, Steven M. (2010) PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: Results of a randomized phase IIa trial. Australasian Journal of Dermatology, 51 2: 99-105. doi:10.1111/j.1440-0960.2010.00626.x


Author Siller, Greg
Rosen, Robert
Freeman, Michael
Welburn, Peter
Katsamas, Janelle
Ogbourne, Steven M.
Title PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: Results of a randomized phase IIa trial
Journal name Australasian Journal of Dermatology   Check publisher's open access policy
ISSN 0004-8380
1440-0960
Publication date 2010-05-01
Sub-type Article (original research)
DOI 10.1111/j.1440-0960.2010.00626.x
Volume 51
Issue 2
Start page 99
End page 105
Total pages 7
Place of publication Richmond, Australia
Publisher Wiley-Blackwell Publishing Asia
Collection year 2011
Language eng
Formatted abstract
Objectives: To evaluate the safety of two applications of PEP005 (ingenol mebutate) gel in superficial basal cell carcinoma. Efficacy was a secondary end-point.
Methods: Randomized, vehicle-controlled, phase IIa study conducted at eight private dermatology clinics in Australia. A total of 60 patients with histologically confirmed superficial basal cell carcinoma (lesion size, 4–15 mm) were randomized to treatment on days 1 and 2 (Arm A) or days 1 and 8 (Arm B) and, within each arm, to ingenol mebutate gel, 0.0025%, 0.01% or 0.05%, or vehicle gel. The main outcome measures were the incidence and severity of adverse events and local skin responses in Arms A and B; lesion clearance at day 85 was a secondary measure.
Results: The incidence of adverse events was low. One patient treated with ingenol mebutate gel, 0.05% in Arm A experienced severe flaking/scaling/ dryness extending beyond the application site. Nonsevere, potentially treatment-related events included erythema extending beyond the application site, application-site pain and headache in two patients each. Six patients in Arm A had one or more severe local skin responses. Efficacy appeared to be doserelated and there was a trend towards higher clinical and histological lesion clearance rates in Arm A compared with Arm B. Histological clearance occurred in five of eight patients (63%) randomized to ingenol mebutate gel, 0.05% in Arm A.
Conclusions:
Two applications of ingenol mebutate gel, 0.05%, are safe and have efficacy in patients with superficial basal cell carcinoma. Key words: anti-neoplastic agent, ingenol mebutate, ingenol-3-angelate, non-melanoma skin cancer, PEP005.
© 2010 The Australasian College of Dermatologists.
Keyword Anti-neoplastic agent
Ingenol mebutate
Ingenol-3-angelate
Non-melanoma skin cancer
PEP005
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2011 Collection
School of Medicine Publications
 
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Created: Sun, 23 May 2010, 10:06:47 EST