Efficacy and safety evaluation of cluster mallow extract shampoo for alleviating hair loss symptoms: randomized, double-blind, placebo-controlled study

초록

Objective Hair loss is a common condition that can negatively affect quality of life. This study evaluated the efficacy and safety of a shampoo containing 0.25% Malvae Semen (seeds of Malva verticillata L.) extract (MSE) for alleviating hair-loss-related symptoms and improving hair-related parameters. Methods This randomized, double-blind, placebo-controlled, single-center clinical trial included 70 adults with hair loss and was conducted over 24 weeks. Participants were randomly assigned to receive either an MSE-containing shampoo or a control shampoo. Efficacy was evaluated by hair count measurements at the vertex area, investigator visual assessments using standardized photographs, and participant self-assessment questionnaires at baseline and at weeks 8, 16, and 24. Safety was assessed by monitoring vital signs and scalp irritation throughout the study. Results The experimental group showed significant increases in hair count at weeks 8, 16, and 24 compared with baseline (p < 0.05), with a significant difference compared with the control group at week 24 (p < 0.05). No treatment-related adverse events or clinically significant scalp irritation were observed. Conclusions MSE-containing shampoo significantly improved hair count and demonstrated good tolerability, suggesting that it may be a safe cosmetic option for alleviating symptoms of hair loss.

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