Efficacy of Nanofiber Mats Loaded with 5-Fluorouracil and Rosemary Extract on Actinic Keratosis: A Randomized Double-blinded Clinical Trial

Background/Indroduction: Actinic keratosis (AK) is a precancerous skin condition caused by abnormal growth of epidermal keratinocytes. Current treatments, like 5- fluorouracil (5-FU) cream, have limitations. Rosemary extract has shown anticancer and antioxidant properties, enhancing the effects of 5-FU. Nanofibers are a potential drug delivery system due to their unique properties. Thus, this study aimed to investigate the efficacy of 5- FU and rosemary extract-loaded nanofibers in AK treatment. Methods: Polymeric nanofibers loaded with 5-FU and rosemary extract were created using electrospinning. A randomized controlled double-blinded clinical trial was conducted on AK patients, divided into three groups: Group A (nanofibers with 5% 5-FU and rosemary extract), Group B (nanofibers with 5% 5-FU), and Group C (5% 5-FU cream). Improvement, satisfaction, and side effects were assessed using visual analogue scale (VAS) scores and the modified Investigator Global Improvement Score. Results and Discussion: Group A exhibited significantly higher global improvement scores compared to Group B (p value<0.001). Group A also had the highest VAS score, indicating greater patient satisfaction. Side effects were lowest in Group A and highest in Group C. Conclusion: This randomized double-blinded clinical trial suggests that nanofibers loaded with 5-FU and rosemary extract (Group A) are more effective in improving AK lesions compared to nanofibers with 5-FU alone (Group B) and 5-FU cream (Group C). Group A also showed higher patient satisfaction and fewer side effects. The combination of 5-FU and rosemary extract in nanofibers holds promise as an alternative treatment for AK. Further studies are needed to validate these findings and investigate the long-term effects of the treatment. Clinical Trial Registration Number: IRCT20210118050067N1.