Efficacy and safety of ingenol mebutate gel in field treatment of actinic keratosis on full face, balding scalp, or approximately 250 cm2 on the chest: A phase 3 randomized controlled trial

Ingenol mebutate (IngMeb) 0.015% or 0.05% is approved for actinic keratosis (AK) areas of 25 cm2 or less; some patients require treatment of larger fields. To determine efficacy and safety of IngMeb 0.027% in areas of AK of up to 250 cm2 during an 8-week initial assessment period and extended 12-mon...

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Bibliographic Details
Published in:Journal of the American Academy of Dermatology 2020-03, Vol.82 (3), p.642-650
Main Authors: Hanke, C. William, Albrecht, Lorne, Skov, Torsten, Larsson, Thomas, Østerdal, Marie Louise, Spelman, Lynda
Format: Article
Language:English
Subjects:
actinic keratosis
field cancerization
field treatment
ingenol mebutate
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Summary:Ingenol mebutate (IngMeb) 0.015% or 0.05% is approved for actinic keratosis (AK) areas of 25 cm2 or less; some patients require treatment of larger fields. To determine efficacy and safety of IngMeb 0.027% in areas of AK of up to 250 cm2 during an 8-week initial assessment period and extended 12-month follow-up. This phase 3, randomized, double-blind, vehicle-controlled trial (NCT02361216) enrolled adult patients with 5 to 20 AK lesions on the face/scalp (25-250 cm2) or chest (approximately 250 cm2). Patients received once-daily IngMeb or vehicle for 3 consecutive days on the full face, full balding scalp, or approximately 250 cm2 on the chest. The primary endpoint was complete AK clearance (AKCLEAR 100; week 8). Additional endpoints included partial AK clearance (AKCLEAR 75), recurrence, patient satisfaction, cosmetic outcome, and safety. IngMeb was superior to vehicle for complete AK clearance (21.4% vs 3.4%, P 
ISSN:0190-9622
1097-6787
DOI:10.1016/j.jaad.2019.07.083