Hair loss and scalp dysfunction are common and widespread conditions, such as androgenetic alopecia (AGA), which affects a significant portion of the population and can profoundly impact an individual’s psychosocial well-being and quality of life. While conventional FDA-approved treatments like minoxidil and finasteride exist, they often necessitate continuous, long-term use and are associated with limitations, including the risk of rebound hair loss upon discontinuation or hormone-related side effects. This situation drives the exploration of safer, more sustainable alternatives for promoting robust scalp and hair health.
The search for alternatives has focused on promising regenerative approaches, particularly the use of growth factors and plant-derived extracellular vesicles (EVs). Growth factors, specifically insulin-like growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7), are vital regulators of hair follicle regeneration and morphogenesis. These recombinant growth factors were engineered using an Fc-fusion technique to enhance their stability and topical efficacy. Furthermore, plant extracts have gained interest for their regenerative properties, and Centella asiatica (C. asiatica) is notable for its wound-healing and anti-inflammatory attributes. C. asiatica-derived EVs are nanosized particles that efficiently transport bioactive materials, offering enhanced stability and targeted delivery compared to crude extracts. By combining these highly bioavailable components (recombinant long-acting IGF-1 and FGF-7, and C. asiatica EVs) with supportive ingredients like caffeine and panthenol, the researchers sought to evaluate a multi-targeted, non-drug-based intervention for scalp and hair care.
Methods
This was a 56-day exploratory, prospective, randomized, placebo-controlled, double-blinded clinical trial involving 60 healthy adult participants aged 18–60 years. The participants were randomly allocated to one of five parallel groups (n=12 per group), ranging from a placebo control (Group A) to the combined active formulation (Group E: containing the base formula plus recombinant IGF-1, FGF-7, and C. asiatica EV). Participants applied 1 mL of their assigned product once daily in the evening after shampooing. Scalp and hair parameters, including sebum content, hair length, thickness, density, and hair loss (via a 60-stroke combing test), were assessed at baseline and four follow-up intervals.
Key Findings
The study demonstrated that the combination formula (Group E) yielded the most significant and pronounced improvements across all measured parameters compared to the placebo.
• Increased Hair Thickness: Group E showed the greatest effect, with a mean increase of 27.9 µm by Day 56, approximately twice the increase observed in the placebo group (13.9 µm, p < 0.0001). This effect was significantly greater than the C. asiatica EV group (Group D) alone, suggesting a synergistic effect.
• Enhanced Hair Density: By Day 56, Group E resulted in a 23.9% increase in hair density relative to baseline, nearly double the 11.9% increase seen in the placebo group (p < 0.001).
• Accelerated Hair Length: Group E achieved the greatest mean cumulative hair growth (3.5 cm) by Day 56, which was significantly higher than the placebo group (p < 0.001). Significant differences were evident as early as Day 14 (p < 0.0001).
• Reduced Sebum Content: Group E demonstrated a 59% reduction in sebum production relative to baseline, significantly outperforming both the placebo (p < 0.01) and the base formula Group B (p < 0.05).
• Decreased Hair Loss: Group E exhibited the largest reduction in hair shedding, achieving a 63.6% reduction at Day 56 compared to a 43.1% reduction in the placebo group (p < 0.05).
The research represents a significant step by being the first human trial to combine plant-derived Extracellular Vesicles (C. asiatica EV) with engineered, recombinant long-acting growth factors (rIGF-1 and rFGF-7) for cosmetic application in scalp and hair care. The observed substantial improvements strongly suggest a synergistic interaction between the plant-derived EVs and the recombinant growth factors. This combined approach offers a novel cosmetic pathway to improve follicular and scalp microenvironment health, positioning it as an alternative distinct from conventional drug-based alopecia treatments.
Looking ahead, this exploratory study provides preliminary evidence to support future investigations. Key implications involve confirming the long-term safety and efficacy beyond the initial 56-day period, as hair growth cycles typically span several months. Furthermore, future studies should aim to elucidate the precise mechanistic biomarkers involved in this synergistic action. Since the current cohort was relatively young and predominantly female, further research in middle-aged and older individuals, utilizing a balanced gender ratio, is warranted to confirm the generalizability and effectiveness of this combination in populations experiencing more advanced androgenetic alopecia or age-related follicular decline.
The development of this essence is akin to creating a specialized delivery truck (the EV) that ensures potent cargo (the growth factors) reaches the intended destination (the hair follicle) efficiently, promising a more effective and sustainable solution than traditional options.
Link to the study: https://www.mdpi.com/2079-9284/12/6/253
