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

NCT04048031 | Completed

• 1 other identifier: ASIRC-NW-02
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hair Thinning

Keywords

Hair thinning; Hair Loss; Women; Perimenopausal, Menopausal and Post Menopausal Women; Nutraceutical supplement

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  180 days

Secondary Outcomes (9)

• Number of terminal hairs, number of vellus hairs, and number of total hairs in the target area of the scalp

  nine (9) month and twelve (12) month visits

• Dino-Lite microscopic photographs for terminal hair diameter measurements in the target area

  Day 0, Day 90, Day 180, Day 270, Day 360

• Hair Washing Procedure in clinic for Hair Shedding Counts

  Day 0, Day 90, Day 180, Day 270, Day 360

• Blinded Physician Global Hair Assessment for Hair Growth and Hair Quality

  Day 90, Day 180, Day 270, Day 360

• Women's Hair Loss Quality of Life Questionnaire

  Day 0, Day 90, Day 180, Day 270, Day 360

Study Arms (3)

Nutrafol Supplement Capsules

ACTIVE COMPARATOR

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. Subjects to take four (4) Nutrafol Supplement capsules by mouth daily for 180 days with a substantial meal.

Dietary Supplement: Nutrafol Supplement Capsules

Placebo Capsules

PLACEBO COMPARATOR

The placebo capsules contain no active ingredients. Subjects to take four (4) Placebo capsules by mouth daily for 180 days with a substantial meal.

Other: Placebo Capsules

Open Label 6 month Extension

OTHER

During the 6 month open label extension all 70 subjects will receive NUTRAFOL's Synergen Complex Plus® which 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. Subjects to take four (4) Nutrafol Supplement capsules by mouth daily for the six month extension with a substantial meal.

Dietary Supplement: Nutrafol Supplement Capsules

Interventions

Nutrafol Supplement Capsules DIETARY_SUPPLEMENT

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.

Nutrafol Supplement Capsules; Open Label 6 month Extension

Placebo Capsules OTHER

The placebo capsules contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial amount of food.

Placebo Capsules

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ablon Skin Institute Research Center: lead
• Nutraceutical Wellness Inc.: collaborator

Study Sites (1)

Ablon Skin Institute & Research Center

Manhattan Beach, California, 90266, United States

Location

Related Publications (2)

• Ablon G, Kogan S, Raymond I. A Long-Term Study of the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women. J Drugs Dermatol. 2022 Jul 1;21(7):783. doi: 10.36849/JDD.776.

  PMID: 35816069 DERIVED

• Ablon G, Kogan S. A Randomized, Double-Blind, Placebo-Controlled Study of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women With Thinning Hair. J Drugs Dermatol. 2021 Jan 1;20(1):55-61. doi: 10.36849/JDD.5701.

  PMID: 33400421 DERIVED

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Glynis Ablon, MD, FAAD

  Ablon Skin institute and Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-Blind with a 6 month Open-Label Exension
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a six (6) month double-blind, randomized, placebo-controlled study with a six (6) month open-label extension to assess the safety and efficacy of Nutrafol® Women's Balance oral supplement in improving hair growth in perimenopausal, menopausal and post-menopausal female subjects with self-perceived thinning hair. After an initial screening period to determine eligibility, subjects will be randomly assigned to one of the following treatment arms: Nutrafol® vs. Placebo for the initial 6 months of the trial. All subjects (Nutrafol® and placebo groups) will receive the active treatment (Nutrafol®) throughout the latter 6-month open-label extension/follow-up period.

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 7, 2019
• Study Start: June 19, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: April 6, 2025

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)