Efficacy and safety of follow‐up field treatment of actinic keratosis with ingenol mebutate 0·015% gel: a randomized, controlled 12‐month study. (9th January 2016)

• Record Type: Journal Article
• Authors: Garbe, C.; Basset‐Seguin, N.; Poulin, Y.; Larsson, T.; Østerdal, M.L.; Venkata, R.; Lear, J.T.
• Is Part Of: British journal of dermatology. Volume 174:Number 3(2016)
• Page Start: 505
• Page End: 513
• Publication Date: 2016-01-09
• Subjects: Dermatology -- Periodicals; Skin -- Diseases -- Periodicals; 616.5
• DOI: 10.1111/bjd.14222
• Languages: English
• ISSNs: 0007-0963

Abstract

Summary: Background: Ingenol mebutate (IngMeb) is a novel patient‐applied topical field therapy for actinic keratosis. Objectives: To demonstrate the efficacy and safety of follow‐up IngMeb field treatment of actinic keratoses (AKs) present at 8 weeks after initial treatment or emerging in a previously cleared field. Methods: In this phase III, randomized, double‐blind study in patients with 4–8 clinically visible AKs within a contiguous 25‐cm 2 treatment area on the face or scalp, all patients were treated initially with IngMeb 0·015% gel for three consecutive days. If lesions were present in the field at 8 weeks, or emerged at weeks 26 or 44, patients were randomized (2 : 1) to follow‐up IngMeb or vehicle gel for three consecutive days. The main outcome was complete clearance rates of AKs 8 weeks after randomization. Results: Of 450 patients who received initial treatment with IngMeb, 61·6% demonstrated complete clearance at 8 weeks. Patients with AKs present at 8 weeks or emerging at weeks 26 or 44 were randomized to IngMeb ( n = 134) or vehicle ( n = 69). IngMeb achieved a higher complete clearance rate than vehicle 8 weeks after randomization in AKs present at 8 weeks (46·7% vs. 18·4%; P < 0·01) and in emergent AKs (59·5% vs. 25·0%; P = 0·01). Based on those who completed 12 months of follow‐up ( n = 340), the overall 12‐month clearance rate was estimated at 50·0%. Follow‐up IngMeb treatment was well tolerated. Conclusions: This study demonstrated the long‐term benefit of IngMeb 0·015% gel for initial and follow‐up therapy of AKs. Abstract : What's already known about this topic? Actinic keratoses (AKs) are precursors to squamous cell carcinoma (SCC), and regular follow‐up treatments are needed to lower the risk of progression. Improved treatments that target both clinically visible and subclinical AKs may minimize the risk of disease progression. What does this study add? This study provides additional data on the long‐term efficacy of ingenol mebutate and its efficacy with regard to lesions not cleared by initial treatment or emerging over time in a previously cleared field. Linked Comment: Garmyn. Br J Dermatol 2016;174: 481–482 .