Ingenol mebutate in the treatment of actinic keratoses: clearance rate and adverse effects

Abstract

BackgroundActinic keratoses are benign intraepithelial skin neoplasms that develop in photoexposed areas and can progress to invasive carcinoma. They are seen frequently in dermatological practice, occurring in 5.1% of consultations. Ingenol mebutate (IM) was recently approved in Brazil as a topical therapy for field cancerization in actinic keratosis.ObjectiveTo evaluate the clearance rate and adverse events in the treatment of actinic keratoses with ingenol mebutate.MethodsA longitudinal, prospective, non-randomized, interventional, open, single-center study was conducted. Patients with actinic keratoses applied ingenol mebutate on a 25cm2 area of the face and/or scalp for three consecutive days (0.015%) or on the forearm for two days (0.05%).Results27 patients completed the protocol, of whom 13 on the face and/or scalp and 14 on the forearm. Complete clearance occurred in 53.8% in the first group and 42.8% in the second. Partial response was observed in 15.4% and 35.7%, respectively. The most common side effects were erythema, edema, desquamation, pruritus, and local erosion.Study limitationsThe study had a small sample and was not randomized, double-blind, placebo-controlled, or vehicle-controlled.ConclusionIngenol mebutate is well-tolerated for the treatment of actinic keratosis, with good patient adherence thanks to the short treatment period.

Actinic keratoses: review of clinical, dermoscopic, and therapeutic aspects

“…In addition, only three of the 171 patients evaluated in these studies had mild non-treatment-related side effects 147 . In a longitudinal study in the Brazilian population with 27 patients presenting actinic keratoses treated with IM, a complete response was observed in 53.8% of the actinic facial keratoses treated and in 42.8% of the non-facial lesions; in addition, the treatment was well tolerated 148 …”

The Role of Ingenane Diterpenes in Cancer Therapy: From Bioactive Secondary Compounds to Small Molecules

“…However, it was withdrawn from the EU in 2020, due to the observed development of skin cancer in ∼6% of patients using Picato ® . [14][15][16][17][18][19] Several studies regarding the isolation, synthesis, and anticancer 1 effects of diterpenoids from Euphorbia species have been published. These diterpenoids were reported to have antiproliferative, 20 cytotoxic, 21 antimicrobial, 22 and antipyretic-analgesic activities.…”

Retrospective analysis of squamous cell carcinoma associated with ingenol mebutate reported to the US Food and Drug Administration

“…In the There are limited data showing an association of ingenol mebutate with development of SCC. 2,[7][8][9] However, there appear to be more SCC cases associated with ingenol mebutate compared to other topical AK drugs in FAERS ( Table 1). The FDA has recently started an investigation on the safety of ingenol mebutate for the treatment of AK.…”