INDIVIDUAL ARTICLE: Safety and Tolerability of Topical Agents for Actinic Keratosis: A Systematic Review of Phase 3 Clinical Trials.

BACKGROUND

Topical agents for actinic keratosis (AK), along with cryotherapy and phototherapy, are the most commonly used therapies for areas of skin with multiple AKs. Multiple options for the topical treatment of AK exist; newer therapies aim to balance efficacy with an acceptable safety and tolerability profile for the patient.

OBJECTIVE

To describe the safety and tolerability of FDA-approved topical agents for the treatment of AK.

METHODS

A systematic review of phase III clinical trials of topical agents for AK available on PubMed and clinicaltrials.gov was conducted on January 10th, 2021.

RESULTS

29 phase III clinical trials meeting the inclusion criteria were included in the qualitative synthesis. No serious adverse events or systemic adverse events were determined to be due to topical therapies for AK. The highest rates of treatment-related application-site adverse events and local skin reactions occurred with the various formulations of topical 5-FU and imiquimod; newer topical agents such as ingenol mebutate and tirbanibulin had more favorable tolerability profiles.

CONCLUSIONS

FDA-approved topical agents for the treatment of multiple AKs have minimal safety concerns. Tolerability profiles vary among the available options, and new agents such as tirbanibulin offer a favorable combination of safety, tolerability, and efficacy. J Drugs Dermatol. 2021;20:10(Suppl):s4-11.