Reducing unpleasant side effects of topical 5-Fluorouracil treatment for actinic keratosis: a randomized controlled trial.

Introduction

5-Fluorouracil (5-FU) for prophylactic treatment of diffuse actinic keratosis results in an exuberant inflammatory reaction, contributing to patient noncompliance and dissatisfaction.

Design

This 5-week split-faced, double-blind, randomized controlled trial involved 30 subjects with diffuse facial AK who received twice daily 5-FU treatment for 2 weeks. This was followed by pre-randomized twice daily use of one of three topical interventions on one half of the face. TEWL, pH, and hydration were assessed on each quadrant of the face at all visits. Additionally, photographs were subjectively graded by three blinded trained observers.

Results

Thirty subjects were enrolled, and had an average 27.1 (SD 11.8, range: 13-62) palpable AKs at baseline. Average resolution of baseline AK count was 98.1% by week 4. Clobetasol propionate is best at decreasing TEWL (p = .034), while petrolatum jelly most significantly improves hydration (p = .019) and erythema (p = .014). Though controlled release skin barrier emulsion trended towards improvement in TEWL (p = .17) and hydration (p = .19), there was no significant decrease in erythema (p = .257). Patient free-text response identified erythema as the most bothersome symptom.

Conclusions

Given the low cost, wide availability, and ability to significantly reduce erythema, petrolatum should be used for post-5-FU treatment for diffuse AK.