Hair Thinning Clinical Trial
Official title:
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
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.
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.
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