NCT04048031

Efficacy and Safety of a Nutraceutical Supplement With Standardized Botanicals in Peri-menopausal and Menopausal Women With Thinning Hair

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Ability And Safety Of A Nutraceutical Supplement With Standardized Botanicals To Promote Hair Growth In Perimenopausal, Menopausal And Post-Menopausal Women With Self-Perceived Thinning Hair

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Ablon Skin Institute Research Center · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

NUTRAFOL® Women's Balance supplement is a novel nutraceutical supplement, scientifically formulated to specifically target the multiple underlying causes of hair loss and thinning in women. NUTRAFOL® Women's Balance capsules are comprised of primary and secondary ingredients, designed to restore hair health from the inside out. In addition to the necessary vitamins, minerals, proteins to support the nutritional needs of hair, it also contains nutraceutical-grade botanical bioactives that are standardized and clinically tested. The formulation leverages the multidimensional properties of power plants, which possess a full spectrum of phytochemicals with innate capacities to work in synergy with each other to fulfill their specific therapeutic roles. Using the latest biotechnology, these ingredients are bio-optimized and standardized, extracted with patented methods that preserve their bioactive integrity and made more bio-available and bio-absorbable via specific patented technologies. Ingestion of NUTRAFOL® Women's Balance supplement over a six (6) month period will strengthen and promote the growth of hairs in perimenopausal, menopausal, and post-menopausal female subjects with self-perceived thinning hair when compared to baseline and those using the placebo tablet, with further improvement during the subsequent six (6) month open-label extension period.

Detailed description

NUTRAFOL® Women's Balance supplement is a novel nutraceutical supplement, scientifically formulated to specifically target the multiple underlying causes of hair loss and thinning in women. NUTRAFOL® Women's Balance capsules are comprised of primary and secondary ingredients, designed to restore hair health from the inside out. In addition to the necessary vitamins, minerals, proteins to support the nutritional needs of hair, it also contains nutraceutical-grade botanical bioactives that are standardized and clinically tested. The formulation leverages the multidimensional properties of power plants, which possess a full spectrum of phytochemicals with innate capacities to work in synergy with each other to fulfill their specific therapeutic roles. Using the latest biotechnology, these ingredients are bio-optimized and standardized, extracted with patented methods that preserve their bioactive integrity and made more bio-available and bio-absorbable via specific patented technologies. NUTRAFOL's Synergen Complex Plus® is a formulation based on a patent-pending Synergen Complex®, a combination of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant, DHT-inhibiting and hormone-rebalancing properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. Some key ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol complex, gelatinized Maca, Astaxanthin, Bioperine (piperine), and Capsimax (capsaicin), all of which are bio-optimized and clinically tested. Ingestion of NUTRAFOL® Women's Balance supplement over a six (6) month period will strengthen and promote the growth of hairs in perimenopausal, menopausal, and post-menopausal female subjects with self-perceived thinning hair when compared to baseline and those using the placebo tablet, with further improvement during the subsequent six (6) month open-label extension period. The primary endpoints will be favorable analysis using the Canon Power Shot G16 with 3GEN Dermlite FOTO Pro for macrophotography hair count analysis of terminal, vellus and total hairs at three (3) and six (6) months. The secondary endpoints will include favorable analysis using the Canon Power Shot G16 with 3GEN Dermlite FOTO Pro for macrophotography hair count analysis of terminal, vellus and total hairs at nine (9) and twelve (12) month visits. Other secondary endpoints will be favorable improvement in terminal hair diameter measured by the Dino-Lite Digital Microscopic, favorable improvement in the Blinded Physician Global Hair Assessments for hair growth and hair quality, decrease in hair shed counts with Hair Washing Procedure, statistically significant positive feedback on the Women's Hair Loss Quality of Life, Self-Assessment, Subject Treatment Satisfaction and Ease of Use, Subject Hair Satisfaction and Menopause Rating Scale Questionnaires at the three (3), six (6), nine (9) and twelve (12) month visits. The exploratory endpoint would be favorable improvement in the Hair Check device hair bundle measurement for Hair Mass Index (HMI) at the three (3), six (6), nine (9) and twelve (12) month visits. See Table of Study Procedures. A minimum of seventy (70) female subjects will be enrolled in this clinical study; Forty (40) subjects will receive active and Thirty (30) subjects will receive placebo.

Conditions

• Hair Thinning

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutrafol Supplement Capsules	NUTRAFOL's Synergen Complex Plus® is a formulation based on a patent-pending Synergen Complex®, a combination of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant, DHT-inhibiting and hormone-rebalancing properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. Some key ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol complex, gelatinized Maca, Astaxanthin, Bioperine (piperine), and Capsimax (capsaicin), all of which are bio-optimized and clinically tested. The Nutafol supplement capsules are compared to the placebo capsules which contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial meal.
OTHER	Placebo Capsules	The placebo capsules contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial amount of food.

Timeline

• Start date: 2019-06-19
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2019-08-07
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States