RCT of Prebiotic Panthenol Balm to Improve 5-FU Tolerability in Actinic Keratoses

Overview

This randomized controlled trial assessed whether adjunctive use of a prebiotic and panthenol-containing repair balm (BB5+) improves tolerability and adherence to topical 5-fluorouracil (5-FU) therapy for actinic keratoses. While BB5+ did not significantly increase treatment completion rates, it reduced local skin reaction severity and improved quality of life, especially for facial field therapy.

Background

Actinic keratoses (AKs) are common precancerous lesions arising from sun-damaged skin and represent an early stage in keratinocyte cancer development. Topical 5% fluorouracil (5-FU) is a highly effective field therapy with chemopreventive benefits but is often limited by local skin reactions (LSRs) that reduce treatment adherence. Strategies to improve skin barrier function and reduce LSRs during 5-FU therapy are an unmet clinical need. The repair balm Baume B5+ (BB5+) contains panthenol and prebiotics with properties that may enhance skin barrier repair and reduce inflammation.

Data Highlights

Key Findings

• Adjunctive BB5+ repair balm did not significantly increase the rate of treatment completion with topical 5-FU.
• Use of BB5+ significantly reduced the severity of local skin reactions associated with 5-FU therapy.
• Quality of life measures improved notably in patients using BB5+, particularly those receiving facial field therapy.
• Barrier repair strategies like BB5+ may improve patient tolerability without compromising 5-FU treatment exposure.
• The study supports the potential role of adjunctive skin barrier support to enhance the patient experience during field therapy for AKs.

Clinical Implications

Incorporating a prebiotic and panthenol-containing repair balm alongside topical 5-FU therapy may help mitigate local skin reactions and improve patient quality of life, potentially enhancing adherence in clinical practice. Although treatment completion rates were not significantly increased, barrier repair represents a simple and accessible adjunctive strategy to support tolerability during AK field therapy.

Conclusion

Adjunctive use of BB5+ repair balm during topical 5-FU therapy for actinic keratoses reduces local skin reaction severity and improves quality of life without compromising treatment adherence. Barrier repair approaches warrant consideration to optimize patient experience during field-directed AK treatment.

References

1. Australian Institute of Health and Welfare 2023 -- Skin Cancer in Australia
2. Rosen et al. 2013 -- Standardized Grading of Local Skin Reactions
3. Smith et al. 2022 -- Efficacy of Baume B5+ in Dermatologic Treatments