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Ingenol Mebutate (Picato): Topical Treatment of Non-hyperkeratotic, Non-hypertrophic Actinic Keratosis in Adults [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Feb.

Cover of Ingenol Mebutate (Picato)

Ingenol Mebutate (Picato): Topical Treatment of Non-hyperkeratotic, Non-hypertrophic Actinic Keratosis in Adults [Internet].

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REFERENCES

1.
Pharmacoeconomic evaluation. In: CDR submission binder: Picato® (ingenol mebutate) topical gel 0.015% and 0.05% [CONFIDENTIAL manufacturer's submission]. Thornhill (ON): LEO Pharma Inc; May, 2013.
2.
Clinical study report PEP005-016: A multi-center, randomized, parallel group, double-blind, vehicle-controlled study to evaluate the efficacy and safety of PEP005 (ingenol mebutate) gel, 0.015% in patients with actinic keratoses on the head (face or scalp) (REGION-IIa) [CONFIDENTIAL internal manufacturer's report]. Bowen Hills, QLD (Australia): Peplin Operations Pty Ltd; Sep 8, 2010.
3.
Clinical study report PEP005-025: A multi-center, randomized, parallel-group, double-blind, vehicle controlled study to evaluate the efficacy and safety of PEP005 (ingenol mebutate) gel, 0.015% in patients with actinic keratoses on the head (face or scalp) (REGION-IIb) [CONFIDENTIAL internal manufacturer's report]. Bowen Hills, QLD (Australia): Peplin Operations Pty Ltd; Sep 8, 2010.
4.
Clinical study report PEP005-014: A multi-center, randomized, parallel group, double-blind, vehicle-controlled study to evaluate the efficacy and safety of PEP005 (ingenol mebutate) gel, 0.05% in patients with actinic keratoses on non-head locations (REGION-I) [CONFIDENTIAL internal manufacturer's report]. Bowen Hills, QLD (Australia): Peplin Operations Pty Ltd; Sep 16, 2010.
5.
Clinical study report PEP005-028: A multi-center, randomized, parallel group, double-blind, vehicle-controlled study to evaluate the efficacy and safety of PEP005 (ingenol mebutate) gel, 0.05% in patients with actinic keratoses on non-head locations (REGIONIb) [CONFIDENTIAL internal manufacturer's report]. Bowen Hills, QLD (Australia): Peplin Operations Pty Ltd; Sep 8, 2010.
6.
Gupta AK, Paquet M, Villanueva E, Brintnell W. Interventions for actinic keratoses. Cochrane Database Syst Rev. 2012;12:CD004415. [PMC free article: PMC6599879] [PubMed: 23235610]
7.
Australian Government. Department of Health and Ageing. Ingenol, gel, 0.15 mg per g (0.015%), 70 mcg ingenol mebutate in 0.47 g single use tubes, 3, Picato® [Internet]. Canberra: Commonwealth of Australia; 2012. [cited 2013 Jul 18]. Available from: http://www​.pbs.gov.au​/info/industry/listing​/elements/pbac-meetings​/psd/2012-11/ingenol.
8.
National Institute for Health and Care Excellence. ESNM14: actinic keratosis: ingenol lmebutate gel [Internet]. London: The Institute; 2013. [cited 2013 Jul 18]. Available from: http://publications​.nice​.org.uk/esnm14-actinic-keratosis-ingenol-mebutate-gel-esnm14​/relevance-to-nice-guidance-programmes.
9.
Scottish Medicines Consortium. Ingenol mebutate, 150 & 500 micrograms/g, gel Picato®. LEO Laboratories. SMC no. (851/13) [Internet]. Glasgow: NHS Scotland; Mar 11, 2013. [cited 2013 Jul 29]. Available from: http://www​.scottishmedicines​.org.uk/files​/advice/ingenol_mebutate​_gel_Picato_FINAL​_FEBRUARY_2013_amended_04​.03.13_for_website.pdf.
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Bookshelf ID: NBK195588

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