Marc Bourcier1, Linda Stein Gold2, Lyn Guenther3, Camilla M Andreassen4, Johan Selmer4, Gary Goldenberg5. 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.
RCT Entities:
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.
Entities:
Keywords:
Actinic keratosis; field cancerization; ingenol disoxate; ingenol mebutate
Authors: Daniel M Siegel; Stephen Tyring; Walter K Nahm; Marie Louise Østerdal; Astrid H Petersen; Brian Berman Journal: J Clin Aesthet Dermatol Date: 2017-12-01
Authors: Brian Berman; Stephen Tyring; Walter K Nahm; Marie Louise Østerdal; Astrid H Petersen; Daniel M Siegel Journal: J Clin Aesthet Dermatol Date: 2017-11-01