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

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ClinicalTrials.gov Identifier: NCT03206567
Recruitment Status : Unknown
Verified June 2017 by Ablon Skin Institute Research Center.
Recruitment status was:  Recruiting
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Nutraceutical Wellness Inc.
Information provided by (Responsible Party):
Ablon Skin Institute Research Center

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.


Condition or disease Intervention/treatment Phase
Hair Thinning Dietary Supplement: Nutrafol Supplement capsules Other: Placebo capsules Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind study
Primary Purpose: Treatment
Official Title: A 6-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Ability and Safety of a Nutraceutical Supplement With Standardized Botanicals to Promote Hair Growth in Women With Self-Perceived Thinning Hair
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nutrafol Supplement capsules
Subjects to take four (4) Nutrafol Supplement capsules by mouth daily for 180 days with a substantial meal
Dietary Supplement: Nutrafol Supplement capsules
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.

Placebo Comparator: Placebo Capsules
Subjects to take four (4) Placebo capsules by mouth daily for 180 days with a substantial meal.
Other: Placebo capsules
The placebo capsules contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial meal.




Primary Outcome Measures :
  1. Number of terminal hairs in the target area of the scalp. [ Time Frame: 180 days ]
    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.

  2. Number of vellus hairs in the target area of the scalp. [ Time Frame: 180 days ]
    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.


Secondary Outcome Measures :
  1. Dino-Lite microscopic photographs for terminal hair diameter measurements in the target area. [ Time Frame: 180 days ]
    Dino-Lite Microscopic digital photographs to measure the diameter of the hair will be taken of the selected target area of each subject at each visit as specified under the Schedule of Procedures. Ten (10) terminal hairs just on the border of the 2 cm x 2 cm area used for the Hair Check HMI will be randomly chosen (not all from one direct area) and cut at the surface of the scalp thus not creating any bald patches. The hair diameter will then be measured at 1mm from the cut end of the hair. All calibrations and measurement will be done at the setting of 230X. The ten (10) hair measurements will then be recorded in the source and averaged to attain a median hair diameter for the target area.

  2. Hair Check device hair bundle measurement for Hair Mass Index (HMI). [ Time Frame: 180 days ]
    After attaining the target site (see target site selection section) and the four outer markings this will indicate the target area of 1 cm by 1 cm. Then the Hair Check 4-legged (2 cm x 2 cm) marking template will be placed around the triangulation point and target area. This 2 x 2 cm area will now be used for the creation of the bundle of hair to be measured for Hair Mass Index (HMI).

  3. Quality of Life Questionnaire [ Time Frame: 180 days ]
    Questionnaire about the subjects and how their life is affected by thinning hair.

  4. General Lifestyle Questionnaire [ Time Frame: 180 days ]
    Questionnaire about the subjects general lifestyle and how their life is affected by thinning hair.

  5. Physician Global Hair Assessment [ Time Frame: 180 days ]

    Investigator Hair Growth Global Improvement Scale:

    The treating investigator will complete this live assessment by circling the number on the scale that corresponds to the description that best fits the current global growth improvement at delinated visits as indicated in the schedule of events. The blinded investigator will complete this assessment during the study at Day 90 and Day 180 visits.

    Investigator Hair Quality Global Improvement Scale:

    The treating investigator will complete this live assessment by circling the number on the scale that corresponds to the description that best fits the current hair quality at delinated visits as indicated in the schedule of events. Assessment grading is to be based upon the investigator's appraisal of hair brittleness, dryness, texture, shine, scalp coverage and overall appearance. The blinded investigator will complete this assessment during the study at Day 90 and Day 180 visits.


  6. Self-Assessment Questionnaire [ Time Frame: 180 days ]
    Questionnaire is the evaluation of the growth and qualities related to the subjects hair.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Females, ages 21-65 years of age.
  2. Clinically-determined general good health as determined by responses to the initial study assessment.
  3. 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).
  4. Females willing to maintain their normal hair shampooing frequency.
  5. Females willing to add the provided oral supplement to their current daily routine.
  6. 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.
  7. 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.
  8. 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.
  9. Females with Fitzpatrick I-IV photo skin types.
  10. 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.
  11. Willingness to have digital macrophotography of the target area and scalp for hair counts at Visits 1, 2 and 3.
  12. Willingness to have a bundle of hair measured by the Hair Check device for Hair Mass Index (HMI) at Visits 1, 2 and 3.
  13. 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.
  14. 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.
  15. 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).

Exclusion Criteria:

  1. Females with any known allergy or sensitivity to any shampoo/conditioner.
  2. Females who are nursing, pregnant, planning to become pregnant during the study.
  3. Females with known stressful incident within the last six months (ie. death in family, miscarriage)
  4. Females who are participating on any clinical research study at ASIRC or at another research center or doctor's office.
  5. 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).
  6. Females currently using any Low Level Laser Therapy (LLLT) to treat thinning hair.
  7. Females who have regularly used Rogaine (Minoxidil) within the last 3 months.
  8. 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).
  9. 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.
  10. No history of burning, flaking, itching, and stinging of the scalp.
  11. History of malignancy (except scc and bcc skin cancers) or undergoing chemotherapy or radiation treatments.
  12. 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.
  13. A known history of depression or bi-polar disease or any other condition that may impact the subject's participation.
  14. Is involved in any injury litigation claims.
  15. 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.
  16. Individuals with self-reported uncontrolled diseases (i.e. diabetes, hypertension, hyperthyroidism, hypothyroidism, etc.). Medical conditions that are under control with or without treatment will be considered on an individual basis by the Investigator.
  17. Females with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.
  18. 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.).
  19. Use of any medications that are known to potentially cause hair loss or affect hair growth, as determined by PI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206567


Contacts
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Contact: Shelley Joyce, RN, BSN, CRC 310-727-3376 shelley@abloninstitute.com

Locations
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United States, California
Ablon Skin Institute & Research Center Recruiting
Manhattan Beach, California, United States, 90266
Contact: Shelley Joyce, RN, BSN, CRC    310-727-3376    shelley@abloninstitute.comm   
Principal Investigator: Glynis Ablon, MD, FAAD         
Sponsors and Collaborators
Ablon Skin Institute Research Center
Nutraceutical Wellness Inc.
Investigators
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Principal Investigator: Glynis Ablon, MD, FAAD Ablon Skin Institute Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ablon Skin Institute Research Center
ClinicalTrials.gov Identifier: NCT03206567     History of Changes
Other Study ID Numbers: ASIRC-NW-01
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Ablon Skin Institute Research Center:
Hair thinning, Hair loss, Women, Nutraceutical supplement

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical