PEP005 (ingenol mebutate) gel, a novel agent for the treatment of actinic keratosis: Results of a randomized, double-blind, vehicle-controlled, multicentre, phase IIa study

G Siller; K Gebauer; P Welburn; J Katsamas; Steven Ogbourne

doi:10.1111/j.1440-0960.2008.00497.x

Back

PEP005 (ingenol mebutate) gel, a novel agent for the treatment of actinic keratosis: Results of a randomized, double-blind, vehicle-controlled, multicentre, phase IIa study

Journal article

Peer reviewed

PEP005 (ingenol mebutate) gel, a novel agent for the treatment of actinic keratosis: Results of a randomized, double-blind, vehicle-controlled, multicentre, phase IIa study

G Siller, K Gebauer, P Welburn, J Katsamas and Steven Ogbourne

Australasian Journal of Dermatology, Vol.50(1), pp.16-22

2009

DOI: https://doi.org/10.1111/j.1440-0960.2008.00497.x

Files and links (1)

url

https://doi.org/10.1111/j.1440-0960.2008.00497.xView

Published Version

Abstract

anti-neoplastic agents

field cancerization

field treatment

ingenol-3-angelate

ingenol mebutate

PEP005

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.

Details

Title: PEP005 (ingenol mebutate) gel, a novel agent for the treatment of actinic keratosis: Results of a randomized, double-blind, vehicle-controlled, multicentre, phase IIa study
Authors: G Siller (Author) - University of Queensland
K Gebauer (Author) - Fremantle Dermatology
P Welburn (Author) - Peplin Ltd
J Katsamas (Author) - Peplin Ltd
Steven Ogbourne (Author) - Peplin Ltd
Publication details: Australasian Journal of Dermatology, Vol.50(1), pp.16-22
Publisher: Wiley-Blackwell Publishing Asia
Date published: 2009
DOI: 10.1111/j.1440-0960.2008.00497.x
ISSN: 0004-8380
Organisation Unit: School of Science and Engineering - Legacy; University of the Sunshine Coast, Queensland; School of Science, Technology and Engineering; Centre for Bioinnovation
Language: English
Record Identifier: 99449462902621
Output Type: Journal article

Metrics

2 File views/ downloads

694 Record Views

107 Times Cited - Web of Science

InCites Highlights

These are selected metrics from InCites Benchmarking & Analytics tool, related to this output

Web Of Science research areas: Dermatology

UN Sustainable Development Goals (SDGs)

This output has contributed to the advancement of the following goals:

Source: InCites