More recently, an additional supplement was specifically formulated to provide a multi-targeted approach to thinning hair in women going through the menopausal transition (NUTRAFOL® Women’s Balance, Nutraceutical Wellness Inc., New York, NY). The formulation features the patented Synergen Complex Plus®, a combination of standardized botanicals with clinically tested stress-adaptogenic, antioxidant, antiinflammatory, dihydrotestosterone (DHT)-inhibiting, and hormone-balancing properties. These featured phytoactives include extracts of saw palmetto, maca, astaxanthin, curcumin, tocotrienols, and ashwagandha which are all bio-optimized for enhanced bioavailability.15,16
A prior publication detailing the results of the 6-month randomized, double-blind, placebo-controlled phase of this study demonstrated the ability of this novel nutraceutical supplement to significantly increase the number of terminal and vellus hairs, significantly reduce shedding, as well as improve blinded physician assessments and self-assessments of hair growth and quality.16 The objective of this subsequent 6-month, open-label extension phase was to evaluate the continued safety and efficacy of this nutraceutical supplement for promoting and improving hair growth in perimenopausal, menopausal, and postmenopausal women with self-perceived thinning hair and assess potential long-term benefits on quality of life and menopausal symptoms.
A prior publication detailing the results of the 6-month randomized, double-blind, placebo-controlled phase of this study demonstrated the ability of this novel nutraceutical supplement to significantly increase the number of terminal and vellus hairs, significantly reduce shedding, as well as improve blinded physician assessments and self-assessments of hair growth and quality.16 The objective of this subsequent 6-month, open-label extension phase was to evaluate the continued safety and efficacy of this nutraceutical supplement for promoting and improving hair growth in perimenopausal, menopausal, and postmenopausal women with self-perceived thinning hair and assess potential long-term benefits on quality of life and menopausal symptoms.
MATERIALS AND METHODS
This study was approved by an institutional review board (IRB Company Inc, Buena Park, CA; now Advarra, Inc, Columbia, MD) and conducted in accordance with current standards for Good Clinical Practices as outlined in the United States FDA 21 CFR Part 50. Each subject provided written informed consent prior to participating in any study-related activities. ClinicalTrials.gov Identifier: NCT04048031.
The methods used in this study have been published in detail elsewhere.16 Briefly, study subjects were healthy perimenopausal, menopausal, or postmenopausal women, 40 to 65 years old with Fitzpatrick I–IV photo skin types and self-perceived thinning hair. Selection criteria are listed in Table 1. Initially, 70 subjects were enrolled in the 6-month double-blind randomized placebocontrolled study (Phase I) which was completed by most active- (n=33) and placebo-treated subjects (n=27). After the day 180 evaluation, all 60 remaining subjects entered into a 6-month open-label extension study (Phase II). Subjects originally treated with the active supplement continued with their treatment and previously placebo-treated subjects were switched to treatment with the active supplement (Figure 1). The investigator and both subject groups all remained blinded to the original treatment received during Phase I until the full completion of Phase II.
The methods used in this study have been published in detail elsewhere.16 Briefly, study subjects were healthy perimenopausal, menopausal, or postmenopausal women, 40 to 65 years old with Fitzpatrick I–IV photo skin types and self-perceived thinning hair. Selection criteria are listed in Table 1. Initially, 70 subjects were enrolled in the 6-month double-blind randomized placebocontrolled study (Phase I) which was completed by most active- (n=33) and placebo-treated subjects (n=27). After the day 180 evaluation, all 60 remaining subjects entered into a 6-month open-label extension study (Phase II). Subjects originally treated with the active supplement continued with their treatment and previously placebo-treated subjects were switched to treatment with the active supplement (Figure 1). The investigator and both subject groups all remained blinded to the original treatment received during Phase I until the full completion of Phase II.
