A topical formulation combining Centella asiatica extracellular vesicles (C asiatica EV) with recombinant long-acting insulin growth factor-1 (rIGF-1) and fibroblast growth factor-7 (rFGF-7) significantly improved multiple hair growth parameters in a 56-day randomized controlled trial, according to a preprint published in medRxiv.
The double-blinded study enrolled 60 patients aged 18 to 60 years across 5 groups: placebo control, base formula with 0.1% caffeine and panthenol, base formula plus growth factors, base formula plus C asiatica EV, and a complete formulation that combined all active ingredients. Patients applied approximately 1 mL of their assigned product once daily for 56 days.
The complete formulation (Group E) demonstrated the largest improvements across all measured parameters. Hair shaft thickness increased by a mean of 28 μm at day 56 compared with 14 μm in the placebo group. Hair density rose 24% from baseline vs 12% for placebo. Cumulative hair length growth reached 3.5 cm in the active treatment group vs lower values in placebo, and statistically significant differences emerged as early as day 14.
Sebum content decreased 59% from baseline in Group E compared with 47% reduction in placebo by day 56, achieving statistical significance against both placebo and the base formulation. Hair loss decreased 64% in the complete formulation group vs 43% in placebo at study completion.
The investigators used standardized measurement protocols including the Courage-Khazaka MPA580 system with Sebumeter SM815 probe for sebum quantification and the ScalpX Intelligent Scalp Diagnostic System with 5-megapixel digital microscopy for hair morphometry. Hair loss was assessed via standardized 60-stroke combing tests. All measurements occurred under controlled environmental conditions (20±1°C, 50±5% relative humidity) at HungKuang University in Taichung City, Taiwan.
The researchers tested Fc-fusion modified growth factors designed for extended biological activity. The rIGF-1 was engineered as sr-(Methionyl sh Oligopeptide 2 Dipeptide-46 Oligopeptide-163 sh-Polypeptide 181), while rFGF-7 was formulated as sr-(Methionylsh-Polypeptide-3 Dipeptide-46 Oligopeptide-163 sh-Oligopeptide-197). C asiatica EV were derived from both leaf/petiole and callus tissue.
Randomization employed block randomization with fixed block size of 5, and was implemented via sequentially numbered, opaque, sealed envelopes. The allocation sequence was generated by the principal investigator, and envelope preparation was done by independent staff who were not involved in recruitment or assessment. All 60 enrolled patients completed the study without major protocol violations.
The study population was predominantly female (83% to 92% across groups) with mean age 36 years. Baseline demographic characteristics and measured parameters showed no statistically significant differences across groups.
Repeated measures ANOVA with Greenhouse-Geisser correction assessed within-group changes over time, followed by Dunnett posthoc testing. One-way ANOVA with Tukey honestly significant difference testing evaluated between-group differences at each timepoint.
The investigators acknowledged several limitations. Natural telogen-to-anagen cycling and standardized hair care routines may have contributed to modest improvements even in the placebo group. The 56-day duration may not fully capture long-term follicular cycling patterns. The young, predominantly female cohort limits generalizability to older populations with advanced androgenetic alopecia. The sample size precluded subgroup analyses or regression modeling.
Conventional pharmacologic options for hair loss remain limited by tolerability and long-term adherence concerns, a point the investigators explicitly address in their discussion. “While topical minoxidil and finasteride remain the most widely used growth stimulants, they are known to cause rebound shedding upon discontinuation and side effects that impact quality of life,” the authors wrote. “Therefore, combining growth factor with plant-derived EVs may offer a multi-targeted approach to scalp care.”
The research was conducted at HungKuang University's Department of Applied Cosmetology with collaborators from Schweitzer Biotech Company, China Medical University, Kyoto University's Center for iPS Cell Research and Application, University of Pennsylvania, and Temple University. The trial was registered at ClinicalTrials.gov as NCT06985121.
Schweitzer Biotech Company provided funding and test products but had no role in enrollment, data collection, analysis, or reporting. Several authors disclosed employment or consulting relationships with Schweitzer Biotech Company.
This preprint has not undergone peer review. The authors noted that the findings represent the first human trial evaluating combined plant-derived extracellular vesicles and growth factors for scalp care applications.
Disclosures can be found in the preprint.
Source: medRxiv
