Clinical Study to Evaluate the Efficacy and Safety of a Hair Serum Product in Healthy Adult Male and Female Volunteers with Hair Fall

1Sami Labs Limited, Bangalore, Karnataka 560058, India; 2Sabinsa Corporation, New Jersey, East Windsor 08520, USA; 3ClinWorld Private Limited, Bangalore, Karnataka, India Background: Hair fall is a widespread problem among all genders, ages, and ethnicity with both physical and psychological effects. Objective: This clinical study was designed to evaluate the efficacy and safety of a hair serum formulation containing amla extract, freeze-dried coconut water, and the micronutrient selenium along with sandalwood odorant and peanut shell extract in healthy male and female volunteers with hair fall. Methods: A total of 42 subjects were enrolled and completed the study and they used the test product daily for 90 days. TrichoScan was used to evaluate the efficacy of the test product for improving hair growth rate, hair density, anagen hair, telogen hair, and the density of vellus and terminal hair. Hair thinning and hair fall reduction were compared to its basline by both dermatologists and subject self-assessment questionnaires. Result and Discussion: After 90 days of test product application, there was a significant improvement in hair growth rate (<0.0001), hair density (<0.0001), vellus hair density (<0.0001), and terminal hair density (<0.0001) in comparison to baseline. There was a significant reduction in hair fall with bulb (<0.0001) and without bulb (<0.0001), and hair thinning (<0.0001) compared to the baseline measurement. Adverse events were not recorded during the study. No skin intolerance was reported during the study, and the test product was considered dermatologically safe to use.