Formulation Development and Skin Irritation Testing of Serum Derived from Mycelial Extract of Giant Bolete (Phlebopus portentosus (Berk. & Broome) Boedijn)
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Abstract
Objective: To develop serum formulations containing mycelium extract from the Giant Bolete (Phlebopus portentosus (Berk. & Broome) Boedijn), evaluate their physical and microbiological stability, and assess skin irritation safety in healthy volunteers.
Methods: This study employed a double-blind randomized controlled trial using a within-subject repeated-measures design with randomized test-site allocation. Three serum formulations were prepared containing mycelium extract at concentrations of 0.5%, 1.0%, and 1.5% (w/w). Physical stability was evaluated using the Heating and Cooling Cycle method (6 cycles), and microbiological contamination was assessed according to cosmetic product standards. Skin safety was evaluated using a 48-hour closed patch test in 35 healthy volunteers (14 males and 21 females, aged 22–55 years), with clinical assessments performed according to the International Contact Dermatitis Research Group (ICDRG) criteria. Data were analyzed using the Wilcoxon Signed Rank Test.
Results: All three formulations demonstrated favorable physicochemical properties, presenting as transparent, smooth, and homogeneous gels with a natural light-yellow color. No phase separation was observed following stability testing, and all formulations complied with microbiological quality standards with no pathogenic microorganisms detected. The pH values ranged from 6.55 to 6.58, which fell within the acceptable range for cosmetic products. Skin irritation testing revealed no signs of allergic reactions or irritation among the volunteer at any of the tested concentrations. Statistical analysis confirmed no significant difference in irritation levels compared to the control (Z = 0.000, p = 1.000), demonstrating that the P. portentosus mycelium-based serum was safe and gentle for human skin. These findings provide a scientific foundation for the future commercial development of cosmeceutical products derived from local biological resources.
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