A Pilot Randomized Controlled Trial (RCT) Evaluating the Efficacy of an Exosome-Containing Plant Extract Formulation...

Area of Science:

• Dermatology
• Regenerative Medicine
• Phytochemistry

Background:

• Hair loss negatively impacts self-esteem and psychological well-being.
• Exosomes are promising carriers for therapeutic compounds.
• Plant-derived exosomes offer a novel approach to hair regeneration.

Purpose of the Study:

• To evaluate the efficacy of an exosome formulation (ECPE) derived from Ecklonia cava and Thuja orientalis extracts for male pattern alopecia.
• To assess the safety and hair regrowth potential of ECPE in a randomized controlled trial.

Main Methods:

• A randomized controlled trial involving 20 male participants with Norwood grade 2-3 androgenetic alopecia.
• Participants received either ECPE or a placebo (0.9% sodium chloride) bi-weekly over four sessions.
• Hair density, adverse effects, and self-assessments were used for evaluation.

Main Results:

• The ECPE group showed a significant increase in hair count from baseline to week 16 (p=0.002).
• A significant difference in hair count changes was observed between the ECPE and placebo groups (p=0.006), favoring ECPE.
• ECPE group exhibited higher median hair growth (9.5) compared to placebo (1.5) with a large effect size.

Conclusions:

• ECPE significantly improves hair regrowth in individuals with male pattern alopecia.
• The exosome formulation demonstrated a favorable safety profile with no notable adverse effects.
• ECPE represents a promising therapeutic option for managing androgenetic alopecia.