INTRODUCTION: Topical 5-fluorouracil (5-FU) is an effective field therapy for actinic keratoses (AKs) with proven chemopreventive benefit; however, treatment-limiting local skin reactions frequently impair tolerability and adherence in clinical practice. Our objective is to determine whether adjunctive use of a prebiotic and panthenol-containing repair balm (BB5+ repair balm) improves tolerability and treatment adherence to topical 5-FU field therapy for AKs compared with standard of care alone. METHODS: We conducted a single-blind, randomised controlled trial involving adults prescribed topical 5-FU for AKs on the face/scalp or hands/forearms. Participants were randomised 1:1 to standard of care (5-FU twice daily) or intervention (5-FU twice daily plus BB5+ repair balm applied 30 min after 5-FU), stratified by treatment site and immunocompetence. Primary outcomes were treatment adherence, (≥ 42 applications over four weeks) and worst local skin reaction (LSR) score using a validated severity scale. Secondary outcomes included LSR scores at weeks 1-4 and Dermatology Life Quality Index (DLQI). RESULTS: In all, 59 participants consented, and 50 completed the study (27 intervention, 23 control). Completion of ≥ 42 applications occurred in 59% of the intervention group and 52% of controls (non-significant). Mean total applications were similar between groups (39.6 versus 39.9). The intervention group demonstrated lower mean worst LSR scores compared with standard care (9.2 versus 10.2) with significantly reduced severity at day 14 (p = 0.0435) and day 21 (p = 0.0054), particularly for face/scalp treatments. DLQI scores were significantly improved in facial treatment subgroups receiving BB5+ repair balm. CONCLUSIONS: Although adjunctive BB5+ repair balm did not increase overall treatment completion, it significantly reduced local skin reaction severity and improved quality of life, particularly for facial field therapy. Adjunctive barrier repair may enhance tolerability of topical 5-FU and support patient experience during actinic keratosis treatment. TRIAL REGISTRATION: The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12624000911594).
Tseng et al. (Wed,) studied this question.