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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
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.
The placebo capsules contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial amount of food.
Ablon Skin Institute & Research Center
Manhattan Beach, California, United States
Number of Terminal Hairs in the Target Area of the Scalp
Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of 40 micrometers.
Time frame: 180 days
Number of Vellus Hairs in the Target Area of the Scalp
Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers.
Time frame: 180 days
Number of Total Hairs in the Target Area of the Scalp
Total Hairs equals the sum of Terminal and Vellus Hairs in the Target Area
Time frame: 180 days
Number of terminal hairs, number of vellus hairs, and number of total hairs in the target area of the scalp
Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of 40 micrometers. Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers. Total Hairs equals the sum of Terminal and Vellus Hairs in the Target Area
Time frame: nine (9) month and twelve (12) month visits
Dino-Lite microscopic photographs for terminal hair diameter measurements in the target area
Ten (10) terminal hairs just outside the border of the 2 cm x 2 cm area used for the Hair Check Hair Mass Index (HMI) will be randomly chosen (not all from one direct area) and cut at the surface of the scalp thus not creating any bald patches. The Dino-Lite Microscope will then be used to measure the diameter of each of the ten (10) hairs at 1mm from the cut end of the hair. All calibrations and measurement will be done at the setting of 230X. The ten (10) hair measurements will then be recorded on the Hair Diameter Log Form. All ten (10) diameters will be added together and then divided by 10 to attain an average hair diameter for the area and the average diameter will be recorded in the CRF. See Appendix IV.
Time frame: Day 0, Day 90, Day 180, Day 270, Day 360
Hair Washing Procedure in clinic for Hair Shedding Counts
Subjects will be instructed to wash their hair at home 24 hours in advance of study visits 1, 2, 3, 4 and 5. Subjects will then have their hair washed (shampooed) with a gentle shampoo in the office over a sink containing cheesecloth. The cheesecloth will be positioned to collect shedding hair. The number of hairs collected in the cheesecloth will be counted and recorded. Subjects will be allowed to dry and style their hair. Subjects will have their hair washed and shedding hairs counted on Visits 1, 2, 3, 4 and 5. See Appendix V.
Time frame: Day 0, Day 90, Day 180, Day 270, Day 360
Blinded Physician Global Hair Assessment for Hair Growth and Hair Quality
The treating investigator will complete this live assessment by circling the number on the scale that corresponds to the description that best fits the current global growth improvement and current hair quality Investigator Assessment Scale * 3 Greatly increased * 2 Moderately increased * 1 Slightly increased 0 No change * 1 Slightly worsened * 2 Moderately worsened * 3 Greatly worsened
Time frame: Day 90, Day 180, Day 270, Day 360
Women's Hair Loss Quality of Life Questionnaire
Please complete the following questions by circling the number in the column which best describes your opinion for each characteristic. Very Much (4) A Lot (3) A Little (2) Not At All (1) Not Relevant (0) 1. I am embarrassed by my thinning hair. 2. Because of my thinning hair, I avoid social gatherings. 3. I don't like meeting new people as I feel they are judging me because of my thinning hair. 4. I avoid going out during the day because of my thinning hair. 5. My condition impacts my emotional state at work. 6. I feel my thinning hair has impacted my ability to succeed in interviews. 7. My condition has prevented my participation in a sports activity. 8. My condition impacts my self esteem. 9. My condition makes me feel self conscious about my thinning hair. 10. Because of my thinning hair, I fear being the center of attention. 11. I feel my thinning hair is affecting my personal relationships. 12. Because of my thinning
Time frame: Day 0, Day 90, Day 180, Day 270, Day 360
Self-Assessment Questionnaire
Please complete the following questions by circling the number in the column which best describes your opinion for each characteristic; from +3 (greatly increased/improved) to -3 (greatly decreased/worsened) Greatly Increased/Improved +3 Moderately Increased/Improved +2 Slightly Increased/Improved +1 No Change 0 Slightly Decreased/Worsened -1 Moderately Decreased/Worsened -2 Greatly Decreased/Worsened -3 Overall hair growth Overall hair volume Scalp coverage Thickness of hair body Hair amount Hair quality Hair color Hair shine Hair strength Softness of hair body Amount of new hair Hair growth rate Hair length Ease of styling Overall hair appearance Sleep Quality Overall Well-Being Nail strength +3 Nail Growth rate Growth of Eyebrow hair Growth of eyelashes Skin smoothness Overall skin health Energy levels Libido (Sex drive) Please complete the following questions by circling the number in
Time frame: Day 90, Day 180, Day 270, Day 360
Subject Treatment Satisfaction and Ease of Use Questionnaires
Subject Treatment Satisfaction: Please circle the number on the scale that corresponds to the description that you believe best fits your current satisfaction with the study treatment. Subject Satisfaction Scale Description * 3 Extremely Satisfied * 2 Moderately Satisfied * 1 Slightly Satisfied 0 No change * 1 Slightly Unsatisfied * 2 Moderately Unsatisfied * 3 Greatly Unsatisfied
Time frame: Day 90, Day 180, Day 270, Day 360
Subject Hair Satisfaction Questionnaire
Questionnaire Subject Hair Satisfaction Questionnaire: Please check the box next to the description of your current state of hair health, which most accurately describes your current feelings of how satisfied you are with the amount and quality of hair on your scalp, including scalp coverage, volume and overall appearance. Subject Satisfaction Scale Description * 3 Extremely Satisfied * 2 Moderately Satisfied * 1 Slightly Satisfied 0 No change * 1 Slightly Unsatisfied * 2 Moderately Unsatisfied * 3 Greatly Unsatisfied
Time frame: Day 90, Day 180, Day 270, Day 360
Menopausal Rating Scale Questionnaire
Questionnaire This is a standardized scale and cannot be copied into this document.
Time frame: Day 0, Day 90, Day 180, Day 270, Day 360
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