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

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.

Inclusion criteria

• 1. Females, age 40-65, who are perimenopausal, menopausal or post-menopausal. Perimenopausal is defined as increased variability in menstrual cycle length and defined as persistent difference of 7 days or more in length of consecutive cycles. Later stages include amenorrhea for 60 days or longer and/or vasomotor symptoms. These should have been present for at least 6 months prior to study. Menopause is defined as absence of menstrual bleeding for at least 12 months or 12 months status post complete Hysterectomy with Oophorectomy.

• Clinically-determined general good health as determined by responses to the initial study assessment.

• Females with self-perceived thinning hair as confirmed on initial study assessment by the Investigator (This will not include patients with medically diagnosed telogen effluvium).

• Females willing to maintain their normal hair shampooing frequency.

• Females willing to add the provided oral supplement to their current daily routine.

• Females willing to not substantially change their current diet, medications, or exercise routines for the duration of the study. If a subject receives physician guidance during the study to change diet, medications, or exercise routine, the subject will need to notify the clinic as soon as possible.

• Females willing to undergo a brief physical exam to include height, weight, blood pressure, pulse, general physical findings and a scalp exam. The physical exam will occur at Visits 1, 2, 3, 4 and 5.

• Females with Fitzpatrick I-IV photo skin types.

• Willingness to have 2D digital photography of the entire head/hair region for overall evaluation of general hair growth and fullness at Visits 1, 2, 3, 4 and 5.

• Willingness to have digital macrophotography of the target area and scalp for hair counts at Visits 1, 2, 3, 4 and 5.

• Willingness to have a bundle of hair measured by the Hair Check device for Hair Mass Index (HMI) at Visits 1, 2, 3, 4 and 5.

• Willingness to have ten (10) terminal hairs cut at the base of the scalp from just outside the HMI measurement area for microscopic hair measurements at Visits 1, 2, 3, 4 and 5.

• Willingness to have their hair washed (shampooed) over a sink containing cheesecloth for hair shedding counts at Visits 1, 2, 3, 4 and 5.

• Willingness to maintain a consistent hair cut and hair color throughout the 12 month study period and to come to visits with clean, dry hair.

• Willingness of subjects who have color treated hair to have the color treatment performed at the same time interval prior to each visit (ie. If on Visit 1 the color treatment was done one week prior then the color treatment is expected to occur at a similar interval of one week prior to Visits 2, 3, 4 and 5).

• Willingness of subjects to answer questionnaires related to general lifestyle, quality of life related to hair loss, self-assessment, subject treatment satisfaction and ease of use, subject hair satisfaction and the menopause rating scale at Visits 1, 2, 3, 4 and 5.

Exclusion criteria

• Females who are of childbearing potential defined as still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal.
• Females with any known allergy or sensitivity to any shampoo/conditioner.
• Females with known stressful incident within the last six months (ie. death in family).
• Females who are participating on any clinical research study at ASIRC or at another research center or doctors office.
• Females who have recently (within the last 6 months) started the use of hormone replacement therapy (HRT). Women currently using hormones for HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study (the initiation of HRT should not have been associated with the initiation of hair loss/thinning).
• Females currently using any Low Level Laser Therapy (LLLT) to treat thinning hair.
• Females who have regularly used Rogaine (Minoxidil) within the last 3 months.
• Females who have used prescription drugs known to affect the hair growth cycle within the last 6 months (e.g., cyproterone acetate, aldactone/spironolactone, Finasteride or any 5-alpha-reductase inhibitor).
• Females suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, and telogen effluvium as determined on initial study assessment by the Investigator.
• History of burning, flaking, itching, and stinging of the scalp.
• History of malignancy (except SCC and BCC skin cancers) or undergoing chemotherapy or radiation treatments.
• A known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders that are not controlled in the opinion of the investigator may interfere with the study treatment.
• A known history of depression or bi-polar disease or any other condition that may impact the subject's participation.
• Known history or recent blood work indicating iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as subjects taking anticoagulant therapy, antiplatelet medications, more than one (1) 325 mg ASA on a daily basis or smokers with usage > 20 cigarettes/day.
• Individuals with self-reported uncontrolled diseases (e.g., diabetes, hypertension, hyperthyroidism, hypothyroidism, etc.). All medical conditions that are under control with or without treatment will be considered on an individual basis by the Investigator.
• Females with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.
• Females having a known active dermatologic condition which, in the opinion of the examining Investigators, might place the subject at a greater risk or interfere with clinical evaluations (e.g., seborrheic dermatitis, psoriasis, atopic dermatitis, advanced skin cancer, etc.).
• Use of any medications that are known to potentially cause hair loss or affect hair growth, as determined by the PI.
• Is involved in any injury litigation claims.

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