Efficacy and Safety of a Nutraceutical Supplement With Standardized Botanicals in Women With Thinning Hair

NCT03206567 | Completed

• 1 other identifier: ASIRC-NW-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

NUTRAFOL® is a novel nutraceutical supplement, scientifically formulated to specifically target the multiple underlying causes of hair loss and thinning in women. It does not contain hormones, drugs, or industry by-products. The purpose of this clinical research study is to evaluate the safety, efficacy and physiological effects of NUTRAFOL® supplement compared to placebo in forty (40) female subjects, ages 21-65 years of age with self-perceived thinning hair over the course of six months of continued use.

Conditions

Hair Thinning

Keywords

Hair thinning, Hair loss, Women, Nutraceutical supplement

Outcome Measures

Primary Outcomes (2)

• Number of terminal hairs in the target area of the scalp.

  The first primary efficacy parameter from the digital macrophotographs will be the 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 greater than 40 micrometers. Digital macrophotographs will be taken of the selected target area (1 cm by 1 cm) of each subject at each visit as specified under the Schedule of Procedures. The digital macrophotographs will show the five black colored markings on the scalp that define the target area. Digital macrophotographs will be performed using a Canon Power Shot G16 with 3GEN Dermlite FOTO Pro system.The macrophotographs are then read by the investigator to determine the terminal hair count.

  180 days

• Number of vellus hairs in the target area of the scalp.

  The second primary efficacy parameter from the digital macrophotographs will be the 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. Digital macrophotographs will be taken of the selected target area (1 cm by 1 cm) of each subject at each visit as specified under the Schedule of Procedures. The digital macrophotographs will show the five black colored markings on the scalp that define the target area. Digital macrophotographs will be performed using a Canon Power Shot G16 with 3GEN Dermlite FOTO Pro system. The macrophotographs are then read by the investigator to determine the vellus hair count.

  180 days

Secondary Outcomes (6)

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

  180 days

• Hair Check device hair bundle measurement for Hair Mass Index (HMI).

  180 days

• Quality of Life Questionnaire

  180 days

• General Lifestyle Questionnaire

  180 days

• Physician Global Hair Assessment

  180 days

Study Arms (2)

Nutrafol Supplement capsules

ACTIVE COMPARATOR

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

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

Other: Placebo capsules

Interventions

Nutrafol Supplement capsules DIETARY_SUPPLEMENT

NUTRAFOL's Synergen Complex® is a patent-pending formulation of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant and DHT-inhibiting properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. Some patented ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, USPlus Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol complex, Bioperine (piperine), Cynatine HNS (solubilized keratin), and Capsimax (capsaicin), all of which are standardized and clinically tested. the Nutrafol 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

Placebo capsules OTHER

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

Placebo Capsules

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females, ages 21-65 years of age.
• Clinically-determined general good health as determined by responses to the initial study assessment.
• Females with self-perceived thinning hair as determined 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 and 3.
• Women of child bearing potential should be willing to have a urine pregnancy test and will comply with a medically sound contraception method (including barrier control, abstinence, etc.). Women who are on birth control should have been on it for at least 6 months and willing to continue the same method of birth control. The initiation of birth control should not have been associated with the initiation of hair loss/thinning.
• 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 and 3.
• Willingness to have digital macrophotography of the target area and scalp for hair counts at Visits 1, 2 and 3.
• Willingness to have a bundle of hair measured by the Hair Check device for Hair Mass Index (HMI) at Visits 1, 2 and 3.
• Willingness to have ten (10) terminal hairs from the target area cut at the base of the scalp for microscopic hair measurements at Visits 1, 2 and 3.
• Willingness to maintain a consistent hair cut and hair color throughout the 6 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 and 3).

You may not qualify if:

• Females with any known allergy or sensitivity to any shampoo/conditioner.
• Females who are nursing, pregnant, planning to become pregnant during the study.
• Females with known stressful incident within the last six months (ie. death in family, miscarriage)
• Females who are participating on any clinical research study at ASIRC or at another research center or doctor's office.
• Females who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study (the initiation of HRT or birth control 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., hormone-based birth control for less than 6 months, cyproterone acetate, aldactone/spironolactone, Finasteride or any 5-alpha-reductase inhibitor).
• Females suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia and telogen effluvium as determined on initial study assessment by the Investigator.
• No 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.
• Is involved in any injury litigation claims.
• 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.

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 (1)

• Ablon G, Kogan S. A Six-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Women With Self-Perceived Thinning Hair. J Drugs Dermatol. 2018 May 1;17(5):558-565.

  PMID: 29742189 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 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 study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: May 4, 2017
• Primary Completion: December 10, 2017
• Study Completion: March 1, 2018
• Last Updated: August 7, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)