The hair care industry is experiencing robust growth globally, driven by increasing consumer knowledge and a shift towards natural, organic products.
Androgenetic alopecia (AGA) stands out as the predominant form of hair loss, affecting both sexes. This genetic condition leads to a marked receding hairline in men and general thinning in women, with Caucasians aged 30-50 being most affected. Although treatments like minoxidil and finasteride are FDA-approved for AGA, their side effects often deter long-term use. Consequently, there's an increasing demand for safer, natural alternatives.
Vidya Herbs' Vi-spo™ is a patented formulation of saw palmetto. Renowned for its hair regrowth potential, this ingredient is hailed for its minimal side effects and ancient use by Native Americans. The therapeutic potential of saw palmetto in AGA treatment arises from its ability to block dihydrotestosterone (DHT) formation and support hair follicle health through nourishing fatty acids and antioxidants.
Clinical study
A comprehensive clinical trial evaluated the efficacy of Vi-spo™ in adults with mild to moderate AGA. Over 16 weeks, 80 participants aged 18-50 were divided into groups, receiving either Vi-spo™ or a placebo daily. Objective tests, such as the hair comb and hair pull tests, were utilized alongside photographic analysis. Participants also self-assessed using validated scales addressing hair growth and appearance.
The efficacy of Vi-spo™ was determined using the percentage scalp hair loss estimated by hair comb and hair pull test, hair growth index and hair growth satisfaction scale from baseline.
Salient endpoints analysis
Hair Comb Test A significant (p<0.001) reduction (improvement) in the hair comb test score (Figure 1) from baseline was observed in the Vi-spo™ oral group compared to placebo group subjects.
Hair Pull Test A significant (p<0.001) reduction (improvement) in the hair pull test score (Figure 2) from baseline was observed in the Vi-spo™ oral group compared to placebo control.
Hair Density Analysis The subjects in the test product group receiving Vi-spo™ oral product recorded a significant increase in the normalized hair density ratio (Figure 3), which showed a significant increase (p<0.001) in the hair density from baseline.
Hair Thickness Analysis The subjects in the test product group receiving Vi-spo™ oral product recorded a significant increase (p<0.05) in the normalized hair thickness ratio (Figure 4) from the baseline.
Hair Growth Index Test The quality of existing hair in terms of thickness and hair shaft appearance showed a significant difference (p<0.05) and an equal percent of subjects reported the scales ‘increased’ from baseline in the Vi-spo™ group (50%) compared to placebo group (10.53%) subjects (Figure 5).
Hair Growth Satisfaction Scale (HGSS) For the parameter ‘New hair growth’ a significant (p<0.05) percent of subjects reported the scale ‘increased’ from baseline in the same group.
During the study, no clinically significant changes were observed in the vitals and physical examination of either Vi-spo™ oral and placebo groups, establishing the safety of the products. None of the subjects reported any Serious Adverse Events or were withdrawn from the study due to an Adverse Event or a Serious Adverse Event.
Serum biomarkers (mainly 5-alpha reductase, DHT) and safety assessments, including complete blood count (CBC), aspartate transaminase (AST), alanine transaminase (ALT), blood urea nitrogen (BUN) and serum creatinine, were used for determining safety of the Vi-spo™ oral product efficacy study. At the end of the study, subjects who were administered with Vi-spo™ oral products demonstrated a significant reduction in the dihydrotestosterone in comparison to baseline and subjects in the placebo group.
Figure. 1. Summary of Hair Comb Test Scoring. A significant decrease (p<0.001) in the mean score of hair comb test was recorded in the Vi-spo™ group.
Figure. 2. Summary of Hair Pull Test Scoring. A significant decrease (p<0.001) was recorded in the mean score of hair pull test in the Vi-spo™ group.
Figure. 3. Summary of Normalized Hair Density Ratio. The test group receiving Vi-spo™ recorded a significant increase (p<0.001) in hair density.
Figure. 4. Summary of Normalized Hair Thickness Ratio. Subjects in the test product group receiving Vi-spo™ recorded a significant increase (p<0.001).
Figure. 5. Summary of increase in Hair Growth and Quality based on the percentage reported in the Vi-spo™ study subjects.
Vi-spo™ efficacy and safety in hair loss treatment
The research underscores Vi-spo™ capability to effectively mitigate hair loss symptoms. Comparatively, its performance paralleled the placebo in terms of hair loss severity while demonstrating excellent safety profiles.
"Saw palmetto, in its oral form, not only decelerates hair loss but is also well tolerated without major side effects," remarks Aleksander Richards, Director of Clinical Vidya Herbs.
Looking ahead, Vidya Herbs is gearing up for a study focusing on the gut-hair axis with probiotic and botanical synergy, as mentioned by Subhendu Nayak, Director of Formulation.
Find out more about Vi-spo™ or Vidya Herbs' capabilities.
Bibliography
1. Ho, C. H.; Sood, T.; Zito, M. P.; (2023). Androgenetic Alopecia. StatPearls Publishing.
2. Blumeyer, A.; Tosti, A.; Messenger, A.; et al. (2011). Evidence-based (S3) guideline for the treatment of androgenetic alopecia in women and in men. Journal of the German Society of Dermatology. 9 Suppl 6, S1–S57.
