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

An Bras Dermatol. 2018 Jul-Aug;93(4):529-534. doi: 10.1590/abd1806-4841.20186982.

Abstract

Background: Actinic 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.

Objective: To evaluate the clearance rate and adverse events in the treatment of actinic keratoses with ingenol mebutate.

Methods: A 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%).

Results: 27 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 limitations: The study had a small sample and was not randomized, double-blind, placebo-controlled, or vehicle-controlled.

Conclusion: Ingenol mebutate is well-tolerated for the treatment of actinic keratosis, with good patient adherence thanks to the short treatment period.

Publication types

  • Controlled Clinical Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Diterpenes / adverse effects
  • Diterpenes / pharmacokinetics
  • Diterpenes / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Keratosis, Actinic / drug therapy*
  • Keratosis, Actinic / metabolism
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Prospective Studies
  • Treatment Outcome

Substances

  • 3-ingenyl angelate
  • Diterpenes