Abstract
BACKGROUND: Cordyceps is a valuable Chinese herbal medicine known for its various components with antioxidant properties, which may theoretically improve melasma. This study aimed to evaluate the efficacy of a new skin-lightening cosmetic containing Cordyceps extract (referred to as Cordyceps essence) in treating female patients with melasma. METHODS: Sixty-two women with melasma were enrolled and randomly assigned to two groups for 12 weeks of treatment. Group A received oral tranexamic acid (TXA) combined with topical hydroquinone cream, while Group B received oral TXA combined with topical Cordyceps essence. Changes in the Melasma Area and Severity Index (MASI), melanin index (MI), and erythema index (EI) were monitored and assessed before and after treatment. Patient-reported satisfaction and adverse events were also recorded. Additionally, a metabolomic analysis was conducted on 15 randomly selected patients from Group B. RESULTS: After 12 weeks of treatment, intra-group comparisons revealed that MASI scores, MI, and EI significantly decreased in both Group A and B compared to baseline (p < 0.05). However, inter-group comparisons showed no statistical differences in MASI scores, MI, or EI between the two groups after treatment (p > 0.05). Adverse reactions occurred in 4 people (13.8%) in Group A and 1 person (3.3%) in Group B. Patient satisfaction with treatment was similar in both groups. The metabolomic analysis identified significant differences in 29 metabolites and 15 metabolic pathways after treatment (p < 0.05). CONCLUSIONS: Our study demonstrated that both oral TXA combined with hydroquinone cream and oral TXA combined with Cordyceps essence significantly improved melasma in women. However, the incidence of adverse reactions was lower with topical Cordyceps essence than that with hydroquinone cream. Cordyceps essence appeared to be a promising alternative for patients intolerant to hydroquinone cream. Metabolomic analysis revealed that modulation of melanogenesis-related metabolites, enhanced antioxidant activity, and improved skin barrier function collectively contributed to the clinical improvement in melasma severity. The improvement of melasma with oral TXA and topical Cordyceps essence may be closely linked to changes in endogenous differential metabolites in the skin and the regulation of amino acid metabolic pathways.