Abstract Objective: To evaluate the efficacy and safety of topical La Roche-Posay New B5 Multi-Effect Soothing and Repairing Cream in the treatment of skin adverse reactions related to EGFR inhibitors and capecitabine. Methods: A randomized, double-blind, controlled clinical study was conducted. From October 2024 to June 2025, 40 patients with skin adverse reactions (such as rash, hand-foot syndrome, pruritus, dryness, discoloration, and skin chapping) during anti-tumor therapy (EGFR inhibitors and capecitabine) were recruited from the First Affiliated Hospital of Nanjing Medical University. They were divided into two groups with 20 cases each. The experimental group was treated with topical La Roche-Posay New B5 Multi-Effect Soothing and Repairing Cream, while the control group was treated with topical silicone oil cream, twice daily for 8 weeks. Follow-ups were conducted before treatment and at 2, 4, 6, and 8 weeks after treatment. Efficacy was evaluated based on the improvement rate of rash grade, the improvement time of rash grade, the improvement rate of hand-foot syndrome grade, the improvement time of hand-foot syndrome grade, Visual Analogue Scale (VAS), and Dermatology Life Quality Index (DLQI). Adverse events were recorded. Repeated measures analysis of variance and chi-square test were mainly used to compare efficacy and safety. Results: A total of 40 patients participated in this clinical study, including 22 males and 18 females, with age of (54.21 ± 14.47) years. Before treatment, there were no statistically significant differences between the two groups in gender, age, rash grade, hand-foot syndrome grade, VAS score, or DLQI score (all p 0.05). After 2 weeks of treatment, the improvement rates of rash grade and hand-foot syndrome grade in the experimental group were 20.00% (2/10) and 20.00% (2/10), respectively, while those in the control group were 10.00% (1/10) and 20.00% (2/10), respectively. There were no statistically significant differences between the two groups (p 0.05). After 4 weeks of treatment, the effective rate (rash grade improvement rate + hand-foot syndrome grade improvement rate) in the experimental group was 65.00% (13/20), which was significantly higher than that in the control group (40.00%, 8/20, p 0.05). After 8 weeks of treatment, the effective rate in the experimental group was 70.00% (14/20), which was significantly higher than that in the control group (45.00%, 9/20, p 0.05). After 4, 6, and 8 weeks of treatment, the VAS and DLQI scores in the experimental group were significantly lower than those in the control group (all p 0.05). Conclusion: La Roche-Posay New B5 Multi-Effect Soothing and Repairing Cream is safe and effective in the treatment of skin adverse reactions related to EGFR inhibitors and capecitabine. It can significantly improve rash and hand-foot syndrome after 4 weeks of use and can be applied clinically. Citation Format: X. Yan, Y. Liang, X. Huang, Y. Yin. A Randomized Double-Blind Controlled Study on La Roche-Posay New B5 Multi-Effect Soothing and Repairing Cream in the Treatment of Skin Adverse Reactions Related to EGFR Inhibitors and Capecitabine abstract. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS1-03-15.
Yan et al. (2026) studied this question.