A novel nutraceutical supplement has been specifically formulated to provide a multi-targeted approach to thinning hair in women going through the menopause transition (NUTRAFOL® Women’s Balance, Nutraceutical Wellness Inc., NewYork, NY).The formulation features the patented Synergen Complex Plus®, a combination of standardized botanicals with clinically tested stress-adaptogenic, antioxidant, anti-inflammatory, dihydrotestosterone (DHT)-inhibiting, and hormone-balancing properties. These featured phytoactives include extracts of saw palmetto, maca, astaxanthin, curcumin, tocotrienols, and ashwagandha – all bio-optimized for enhanced bioavailability.12
Here, we present the 6-month interim results of a 12-month, randomized, double-blind, placebo-controlled study assessing the safety and efficacy of this novel nutraceutical supplement in improving growth of hairs (terminal and vellus) in perimenopausal, menopausal, and postmenopausal women with self-perceived thinning hair. To our knowledge, this is a first published study on the use of supplements for hair thinning in women going through the menopausal transition.
Here, we present the 6-month interim results of a 12-month, randomized, double-blind, placebo-controlled study assessing the safety and efficacy of this novel nutraceutical supplement in improving growth of hairs (terminal and vellus) in perimenopausal, menopausal, and postmenopausal women with self-perceived thinning hair. To our knowledge, this is a first published study on the use of supplements for hair thinning in women going through the menopausal transition.
METHODS
Study Subjects
Study participants were healthy female subjects, 40 to 65 years old, with self-perceived thinning hair, as confirmed by a board-certified dermatologist investigator. Subjects were perimenopausal, menopausal or postmenopausal with Fitzpatrick I–IV photo skin types. Perimenopausal was defined as increased variability in menstrual cycle length and characterized by a persistent difference of ≥7 days for consecutive cycles. Later stages included amenorrhea for ≥60 days and/or vasomotor symptoms present for >6 months prior to the study. Menopause was defined as absence of menstrual bleeding for ≥12 months or 12 months status post-hysterectomy with oophorectomy. Enrolled subjects agreed not to substantially change their diet, medications, exercise, hair shampooing routines, and maintain a consistent frequency of haircut and color treatments for the duration of the study. The study was approved by an institutional review board and conducted in accordance with the accepted standards for Good Clinical Practices. All participants provided written informed consent prior to participating.
Reasons for exclusion from study included: allergy or sensitivity to any shampoo or conditioner; a stressful incident within the last 6 months (eg, death in family); recent (<6 months) initiation of hormone replacement therapy (HRT); current use of treatments for thinning hair such as low level laser therapy (LLLT) or minoxidil within the last 3 months; use of other medications that are known to cause hair loss or affect hair growth within the last 6 months (eg, spironolactone, cyproterone acetate, finasteride, or any 5-alpha-reductase inhibitors). Subjects with a known or self-reported history of uncontrolled disease in the opinion of the investigator (eg, autoimmune disorders, thyroid disease, diabetes); documented iron deficiency, bleeding/ platelet disorders, on anticoagulant/antiplatelet therapy or >325mg aspirin daily were excluded, as well as any subjects with a known history of malignancy (except squamous or basal cell carcinoma). Other reasons for exclusion were presence of other hair loss disorders as diagnosed by the investigator, as well as active dermatoses or other health conditions which, in the opinion of the investigator, might place the subject at greater risk or interfere with clinical evaluations.
Test Material
The nutraceutical supplement used in this study (NUTRAFOL® Women’s Balance Capsules, Nutraceutical Wellness Inc., New York, NY) contains a patented Synergen Complex Plus®, a proprietary blend of clinically tested, standardized and bio- optimized phytoactive extracts, in addition to other botanicals, vitamins, and minerals. Some of the key ingredients include standardized extracts of curcumin, ashwagandha, saw palmetto, maca, astaxanthin, tocotrienol-rich tocotrienol/tocopherol complex, capsaicin and piperine, as well as hydrolyzed marine collagen and organic kelp. Placebo capsules consisted of inert material with same appearance. Subjects were instructed to take a dose of four capsules of their assigned therapy with or immediately following a meal, at approximately the same time daily.
Study Procedures
This was a 6-month randomized, double-blind, placebo- controlled trial with a 6-month open label extension phase. The first part of the study consisted of three clinic visits at baseline, day 90, and day 180. The investigator performed a basic physical examination at each visit, including a basic body systems overview, vital signs, and scalp assessments. At the initial visit, the scalp was examined by the investigator to rule out any confounding scalp conditions. Subjects were also queried on general lifestyle practices, including diet, stress, alcohol, smoking, and exercise. A target area was chosen along the frontalis bone, the anterior lateral triangle of the scalp where the lateral and frontal hairlines meet. The location was recorded for future assessments using triangular three- point measurements obtained from the medial canthus, lateral canthus, and preauricular skin pit to the hairline junction. Where these three points met, an approximately 1 cm2 target area was marked and monitored.
Phototrichograms were obtained of the target area during each visit via macrophotography (Canon Power Shot G16 with 3GEN Dermlite FOTO Pro Dermoscopy DSLR lens) for hair count analysis of terminal, vellus, and total hairs. To measure hair shedding, subjects were instructed to wash their hair at home 24 hours in advance of each study visit. At the time of the visit, subjects’ hair was washed with a gentle shampoo over a cheesecloth-covered sink to collect shed hairs, which were counted and recorded.
Study participants were healthy female subjects, 40 to 65 years old, with self-perceived thinning hair, as confirmed by a board-certified dermatologist investigator. Subjects were perimenopausal, menopausal or postmenopausal with Fitzpatrick I–IV photo skin types. Perimenopausal was defined as increased variability in menstrual cycle length and characterized by a persistent difference of ≥7 days for consecutive cycles. Later stages included amenorrhea for ≥60 days and/or vasomotor symptoms present for >6 months prior to the study. Menopause was defined as absence of menstrual bleeding for ≥12 months or 12 months status post-hysterectomy with oophorectomy. Enrolled subjects agreed not to substantially change their diet, medications, exercise, hair shampooing routines, and maintain a consistent frequency of haircut and color treatments for the duration of the study. The study was approved by an institutional review board and conducted in accordance with the accepted standards for Good Clinical Practices. All participants provided written informed consent prior to participating.
Reasons for exclusion from study included: allergy or sensitivity to any shampoo or conditioner; a stressful incident within the last 6 months (eg, death in family); recent (<6 months) initiation of hormone replacement therapy (HRT); current use of treatments for thinning hair such as low level laser therapy (LLLT) or minoxidil within the last 3 months; use of other medications that are known to cause hair loss or affect hair growth within the last 6 months (eg, spironolactone, cyproterone acetate, finasteride, or any 5-alpha-reductase inhibitors). Subjects with a known or self-reported history of uncontrolled disease in the opinion of the investigator (eg, autoimmune disorders, thyroid disease, diabetes); documented iron deficiency, bleeding/ platelet disorders, on anticoagulant/antiplatelet therapy or >325mg aspirin daily were excluded, as well as any subjects with a known history of malignancy (except squamous or basal cell carcinoma). Other reasons for exclusion were presence of other hair loss disorders as diagnosed by the investigator, as well as active dermatoses or other health conditions which, in the opinion of the investigator, might place the subject at greater risk or interfere with clinical evaluations.
Test Material
The nutraceutical supplement used in this study (NUTRAFOL® Women’s Balance Capsules, Nutraceutical Wellness Inc., New York, NY) contains a patented Synergen Complex Plus®, a proprietary blend of clinically tested, standardized and bio- optimized phytoactive extracts, in addition to other botanicals, vitamins, and minerals. Some of the key ingredients include standardized extracts of curcumin, ashwagandha, saw palmetto, maca, astaxanthin, tocotrienol-rich tocotrienol/tocopherol complex, capsaicin and piperine, as well as hydrolyzed marine collagen and organic kelp. Placebo capsules consisted of inert material with same appearance. Subjects were instructed to take a dose of four capsules of their assigned therapy with or immediately following a meal, at approximately the same time daily.
Study Procedures
This was a 6-month randomized, double-blind, placebo- controlled trial with a 6-month open label extension phase. The first part of the study consisted of three clinic visits at baseline, day 90, and day 180. The investigator performed a basic physical examination at each visit, including a basic body systems overview, vital signs, and scalp assessments. At the initial visit, the scalp was examined by the investigator to rule out any confounding scalp conditions. Subjects were also queried on general lifestyle practices, including diet, stress, alcohol, smoking, and exercise. A target area was chosen along the frontalis bone, the anterior lateral triangle of the scalp where the lateral and frontal hairlines meet. The location was recorded for future assessments using triangular three- point measurements obtained from the medial canthus, lateral canthus, and preauricular skin pit to the hairline junction. Where these three points met, an approximately 1 cm2 target area was marked and monitored.
Phototrichograms were obtained of the target area during each visit via macrophotography (Canon Power Shot G16 with 3GEN Dermlite FOTO Pro Dermoscopy DSLR lens) for hair count analysis of terminal, vellus, and total hairs. To measure hair shedding, subjects were instructed to wash their hair at home 24 hours in advance of each study visit. At the time of the visit, subjects’ hair was washed with a gentle shampoo over a cheesecloth-covered sink to collect shed hairs, which were counted and recorded.
