A pilot study evaluating the efficacy and safety of retinaldehyde-loaded niosomes against mild-to-moderate acne

Background: Retinoids are the mainstay of topical therapy for acne. To improve the efficacy and minimize the side effects of retinoids, various novel drug delivery mechanisms, including nanoparticles, have been developed. Aim: To evaluate the efficacy and safety of a retinaldehyde-loaded niosome (RA-N) nanoemulsion against sebum secretion and keratinization on mild-to-moderate acne. Patients/methods: Twenty-three participants exhibiting mild-to-moderate acne with both closed and open comedones were included. They applied a 0.05% RA-N nanoemulsion daily for 4 weeks, did not to use any other emollient or topical pharmaceutical, and were asked to report any symptoms and treatment satisfaction. Results: The participants demonstrated significantly fewer closed and open comedones after 2 and 4 weeks of treatment than at baseline (*p < 0.05). The mean sebum secretion, measured using Sebumeter®, was 327.95 ± 90.20 μg cm⁻² at baseline and reduced to 282.60 ± 99.70 and 250.65 ± 97.6 μg cm⁻², respectively, after 2 and 4 weeks of treatment (*p < 0.05). The mean desquamation index, determined using Visioscan®, was 10.99 ± 1.69 at baseline and decreased to 9.81 ± 1.10 and 8.89 ± 1.32, respectively, after 2 and 4 weeks of treatment (*p < 0.05). The application of the RA-N nanoemulsion resulted in a significantly lower desquamation level, suggesting that the RA-N nanoemulsion was well-tolerated without any skin irritation. None of the participants reported a serious adverse event during this study. Conclusion: Our findings suggest that the RA-N nanoemulsion was effective in improving comedones in acne-prone skin and safe for long-term application. Further studies are necessary to investigate the long-term effects of the application of the RA-N nanoemulsion in participants with inflammatory acne and acne scars.