A recent study showed ingenol mebutate (IngMeb) effectively treated large areas of actinic keratoses (AK).
The phase 3 randomized, double-blind, vehicle-controlled trial included adult participants with 5 to 20 AK lesions on the face/scalp (25 cm2 to 250 cm2) or chest (about 250 cm2). Participants received once daily IngMeb or vehicle for three consecutive days on the full face, full balding scalp, or about 250 cm2 on the chest.
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Complete AK clearance (AKCLEAR 100) at week 8 was assessed as the primary endpoint. Other endpoints included partial AK clearance (AKCLEAR 75), recurrence, patient satisfaction, cosmetic outcomes, and safety.
At week 8, IngMeb was found to be superior to vehicle for achieving AKCLEAR 100 (21.4% vs 3.4%, respectively), as well as AKCLEAR 75 (59.4% vs 8.9%).
The probability of participants treated with IngMeb sustaining clearance during the 12 months of follow-up was 22.9%, the researchers said. IngMeb was also associated with higher treatment-satisfaction and cosmetic outcomes compared with placebo.
In addition, no unexpected safety signals were identified in the study.
“IngMeb 0.027% was superior to vehicle for treatment of AK areas [greater than or equal to] 250 cm2,” the researchers concluded.
Hanke CW, Albrecht L, Skov T, Larsson T, Østerdal ML, Spelman L. 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 III randomized controlled trial [published online July 30, 2019]. J Am Acad Dermatol. doi:10.1016/j.jaad.2019.07.083