Short-Term Follow-Up of a Randomized Controlled Trial of 0.5% and 5% 5-Fluorouracil After Microneedling for Treatment of Facial Actinic Keratoses

Introduction: Topical 5-fluorouracil (5-FU) is used to treat actinic keratosis, although side effects limit treatment. Microneedling might be a tool for reducing treatment duration.

Objective: To evaluate microneedling to promote 5-FU delivery at different concentrations (0.5% and 5%) for actinic keratoses (AKs) treatment.

Methods: Forty-four patients with facial AKs subjected to 1.0 mm microneedling on 1 side of the face were randomized into 5% 5-FU or 0.5% 5-FU groups. Evaluations of efficacy and safety were conducted on days 21 and 111.

Results: Forty-four patients aged 47 to 85 years were enrolled. Complete clearance of AKs was similar within groups for the side of the face treated with microneedling and 5-FU and the side treated with 5-FU alone in both the 5% and 0.5% 5-FU groups. Microneedling and 5% 5-FU was superior to microneedling and 0.5% 5-FU to reduce AKs (p = .025). Microneedling and 5% 5-FU resulted in fewer adverse effects than 5% 5-FU alone (p = .011).

Conclusion: Topical 5% and 0.5% 5-FU delivery for 3 days after microneedling was effective for treating facial AKs and equivalent to 5% and 0.5% 5-FU alone for 15 days after 3 months of follow-up. Microneedling may potentiate 5-FU treatment, reducing treatment time without losing efficacy.