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

Australasian Journal of Dermatology

Volumn 50, Issue 1, 2009, Pages 16-22

  Siller, Greg ^a,d   Gebauer, Kurt ^b   Welburn, Peter ^c   Katsamas, Janelle ^c   Ogbourne, Steven M ^c  

^a UNIVERSITY OF QUEENSLAND   (Australia)

^b Fremantle Dermatology   (Australia)

^c Peplin Ltd   (Australia)

^d Siller Medical   (Australia)

Author keywords

Anti neoplastic agents; Field cancerization; Field treatment; Ingenol mebutate; Ingenol 3 angelate; PEP005

Indexed keywords

INGENOL; INGENOL MEBUTATE; UNCLASSIFIED DRUG;

ACTINIC KERATOSIS; ADULT; AGED; ARM; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG STRUCTURE; DRY SKIN; ERYTHEMA; FEMALE; HUMAN; HUMAN TISSUE; MAJOR CLINICAL STUDY; MALE; RANDOMIZED CONTROLLED TRIAL; SKIN BIOPSY; SKIN DEFECT;

ADMINISTRATION, CUTANEOUS; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ARM; AUSTRALIA; DITERPENES; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; ESTERS; FACE; FEMALE; GELS; HUMANS; KERATOSIS, ACTINIC; MALE; MIDDLE AGED; SCALP; TREATMENT OUTCOME;

EID: 58249101137     PISSN: 00048380     EISSN: 14400960     Source Type: Journal    
DOI: 10.1111/j.1440-0960.2008.00497.x     Document Type: Article

References (16)

1. Frost C, Williams G, Green A. High incidence and regression rates of solar keratoses in a Queensland community. J. Invest. Dermatol. 2000 115 : 273 7.
2. Fuchs A, Marmur E. The kinetics of skin cancer: progression of actinic keratosis to squamous cell carcinoma. Dermatol. Surg. 2007 33 : 1099 101.
3. Marks R, Rennie G, Selwood TS. Malignant transformation of solar keratoses to squamous cell carcinoma. Lancet 1988 1 : 795 7.
4. Maiden JH. Weeds of New South Wales. Ag. Gazette NSW 1917 28 : 131 2.
5. Green AC, Beardmore GL. Home treatment of skin cancer and solar keratoses. Aust. J. Dermatol. 1988 29 : 127 30.
6. Aylward JH Peplin Research Pty. Ltd Anti-cancer compounds. US patent 6,787,161. 2004; 7 September.
7. Ogbourne SM, Suhrbier A, Jones B, Cozzi SJ, Boyle GM, Morris M et al. Antitumor activity of 3-ingenyl angelate: plasma membrane and mitochondrial disruption and necrotic cell death. Cancer Res. 2004 64 : 2833 9.
8. Challacombe JM, Suhrbier A, Parsons PG, Jones B, Hampson P, Kavanagh D et al. Neutrophils are a key component of the antitumor efficacy of topical chemotherapy with ingenol-3-angelate. J. Immunol. 2006 177 : 8123 32.
9. Hampson P, Kavanagh D, Smith E, Wang K, Lord JM, Rainger GE. The anti-tumor agent, ingenol-3-angelate (PEP005), promotes the recruitment of cytotoxic neutrophils by activation of vascular endothelial cells in a PKC-δ dependent manner. Cancer Immunol. Immunother. 2008 57 : 1241 51.
10. Ackerman AB, Mones JM. Solar (actinic) keratosis is squamous cell carcinoma. Br. J. Dermatol. 2006 155 : 9 22.
11. Cockerell CJ. Histopathology of incipient intraepidermal squamous cell carcinoma ("actinic keratosis"). J. Am. Acad. Dermatol. 2000 42 : 11 17.
12. Stockfleth E, Kerl E. Guideline Subcommittee of the European Dermatology Forum. Guidelines for the management of actinic keratoses. Eur. J. Dermatol. 2006 16 : 599 606.
13. Roewert-Huber J, Stockfleth E, Kerl H. Pathology and pathobiology of actinic (solar) keratosis - an update. Br. J. Dermatol. 2007 157 (Suppl. 2 18 20.
14. Jeffes EW 3rd., Tang EH. Actinic keratosis. Current treatment options. Am. J. Clin. Dermatol. 2000 1 : 167 79.
15. Vatve M, Ortonne JP, Birch-Machin MA, Gupta G. Management of field change in actinic keratosis. Br. J. Dermatol. 2007 157 (Suppl. 2 21 4.
16. Chia A, Moreno G, Lim A, Shumack S. Actinic keratoses. Aust. Fam. Physician. 2007 36 : 539 43.