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J Dermatolog Treat. 2017 Nov;28(7):652-658. doi: 10.1080/09546634.2017.1303568. Epub 2017 Apr 4.

A dose-finding trial with a novel ingenol derivative (ingenol disoxate: LEO 43204) for field treatment of actinic keratosis on full face or 250 cm2 on the chest.

Author information

1
a Department of Dermatology , Hop G. L. Dumont , Moncton , NB , Canada.
2
b Department of Dermatology , Henry Ford Hospital , Detroit , MI , USA.
3
c Guenther Research Inc. , London , ON , Canada.
4
d LEO Pharma A/S , Ballerup , Denmark.
5
e Department of Dermatology , Icahn School of Medicine at Mount Sinai , New York , NY , USA.

Abstract

PURPOSE:

Actinic keratoses (AKs) may progress to squamous cell carcinoma and can occur in cancerized fields as sub-clinical and clinically visible lesions. Ingenol disoxate gel is a topical field therapy for AK. This Phase I/II trial aimed to assess the safety and efficacy of ingenol disoxate on full face or chest in patients with AKs.

MATERIALS AND METHODS:

Part 1 was a phase-I, open-label, dose-escalation trial investigating the maximum tolerated dose of ingenol disoxate. Part 2 was a phase-II, randomized, double-blind, vehicle-controlled trial; patients were randomized 1:1:1:1 to ingenol disoxate 0.018%, 0.012%, 0.006% gel or vehicle for 2 consecutive days.

RESULTS:

Reduction in AK count from baseline at Week 8 was significantly higher than with vehicle for all doses of ingenol disoxate gel (0.018%, 79.0%; 0.012%, 73.4%; 0.006%, 69.7%; vehicle; 42.3%; p < .001). Local skin responses peaked at Day 3 for all doses, rapidly declined, and reached mild levels at Week 2. Most adverse events were mild or moderate in intensity, and were most commonly application site pain/pruritus.

CONCLUSIONS:

Ingenol disoxate gel is efficacious and well tolerated as field treatment for AKs on the full face or chest. Clinical Trial No.: NCT01922050.

KEYWORDS:

Actinic keratosis; field cancerization; ingenol disoxate; ingenol mebutate

PMID:
28264612
DOI:
10.1080/09546634.2017.1303568
[Indexed for MEDLINE]

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