Treatment of Acne Vulgaris With a Topical Application of Retinaldehyde, Glycolic Acid, and Silybum marianum Fruit Extract: A Pilot Study

Background: In acne-prone skin, the loss of homeostasis leads to aberrant epithelial differentiation, promoting the formation of microcomedones. The maintenance of sebaceous stem cell homeostasis has emerged as a new therapeutic target in acne management. Objective: The aim of this study is to evaluate the efficacy, tolerability, and safety of a topical formulation combining retinaldehyde, glycolic acid, and Silybum marianum fruit extract for the treatment of acne vulgaris. Methods: In this single-arm, open-label, prospective pilot study, eight patients with acne vulgaris were treated with a topical cream containing 7% Silybum marianum fruit extract, 0.1% retinaldehyde, 6% glycolic acid, and thermal spring water. Results: Clinical improvement was observed as early as Day 30, with a significant reduction in the total lesion count (from 401.75 to 322.25; p < 0.05), comedones (from 378.75 to 315.75; p < 0.05), and inflammatory lesions (from 23.25 to 6.75; p < 0.05). When excluding the nasal dorsum, the reduction was even more pronounced: total lesions decreased from 65 to 24.88; non-inflammatory lesions from 40.13 to 18.88; and inflammatory lesions from 21.63 to 6.25 (all p < 0.05). GEA scores progressively improved, with 25% of subjects lesion-free at D30. The mean mCADI score decreased from 6.25 to 5.13. The product was well tolerated with no treatment discontinuation. Conclusions: The investigational topical product containing 7% Silybum marianum fruit extract, 0.1% retinaldehyde, 6% glycolic acid, and thermal spring water proved to be effective, safe, and well tolerated after 30 days of treatment in adults with acne.