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

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.

An Open-Label Single-Arm, Monocentric Study Assessing the Efficacy and Safety of Natural Pterostilbene (Pterocarpus marsupium) for Skin Brightening and Antiaging Effects.

BACKGROUND: Both intrinsic and environmental factors play a role in premature ageing of the skin. Natural extracts have been extensively used to reduce the signs of ageing in recent years. Pterostilbene is a natural analog of resveratrol with therapeutic properties against numerous diseases mainly due to its ability to reduce reactive oxygen species. METHODS: We studied the anti-aging and skin brightening effect of a 0.4% formulation of natural pterostilbene in healthy volunteers (N=38) in an open-label, single-arm, monocentric study for 8 weeks. The melanogenesis inhibitory, anti-tyrosinase and anti-collagenase and anti-elastase properties of pterostilbene were evaluated in vitro. RESULTS: Natural pterostilbene showed significant inhibition of melanogenesis in vitro. Pterostilbene cream (0.4%) was highly effective in reducing markers of aging and induces even skin tone. The product was effective in reducing wrinkles and fine lines, improved skin hydration elasticity and showed no adverse effects. CONCLUSION: Our results suggest that natural pterostilbene is a safe and effective ingredient for use in cosmetic preparation to reduce the markers of skin ageing and brighten the skin tone. TRIAL REGISTRATION: Clinical Trial Registration India Identifier CTRI/2019/01/017160 [Registered on 18/01/2019].

Safety profile of 40% Garcinol from Garcinia indica in experimental rodents.

The present study was taken up to evaluate the single dose acute toxicity, 28 days and 90 days repeated dose toxicity and reproductive/developmental toxicity of standardized 40% Garcinol in experimental rodents. The studies were conducted in compliance with OECD principles of good laboratory practice, guidelines for testing of chemicals no.420, 407, 408 and 421 respectively. Single dose acute oral toxicity was conducted on female Wistar rats as sighting study step-I (300 mg/kg) & sighting study step-II (2000 mg/kg) and main study (2000 mg/kg). Sub-acute, sub-chronic and reproductive/developmental studies were conducted in Wistar rats divided equally in vehicle control, 20, 50 and 100 mg/kg dose group along with recovery groups for vehicle control and high dose. Reproductive/developmental study was carried out for minimum of 28 days and in females during pregnancy and 4 days post partum. There were no abnormal clinical signs/behavioural changes, reproductive and developmental parameters, gross and histopathological changes as well as no alteration in the body weight, body temperature, haematology and other biochemical parameters in all the four studies. 40% Garcinol has a low toxicity profile in rodents and had no observed effects under experimental conditions used.