Efficacy and Safety of a Nutraceutical Supplement With Standardized Botanicals in Women With Thinning Hair
Condition: Hair Thinning
MeSH terms: Alopecia; Alopecia Areata; Hypotrichosis
Study type: Interventional

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.
    

Detailed description: 
      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.

      Ingestion of NUTRAFOL® supplement over a six (6) month period will strengthen and promote the
      growth of hairs in female subjects, ages 21-65 years of age with self-perceived thinning hair
      when compared to using the placebo tablet. The primary endpoints will be favorable analysis
      using the Canon Power Shot G16 with 3GEN Dermlite FOTO Pro for macrophotography hair count
      analysis of terminal and vellus hairs at the three (3) month and six (6) month visits. The
      secondary endpoints will be favorable improvement in terminal hair diameter measured by the
      Dino-Lite Digital Microscopic, favorable improvement in the Hair Check device hair bundle
      measurement for Hair Mass Index (HMI), favorable improvement in the Blinded Physician Global
      Hair Assessments for hair growth and hair quality, statistically significant positive
      feedback on the Women's Hair Loss Quality of Life, Self-Assessment and Subject Treatment
      Satisfaction and Ease of Use questionnaires after six (6) months of NUTRAFOL® supplement or
      placebo ingestion. See Table of Study Procedures.

      All patients enrolled must be identifiable throughout the study. The Investigator will
      maintain a personal list of patient numbers and patient names to enable records to be found
      at a later date and the list will be stored in a locked cabinet. Subject numbers consist of a
      2 digit number from 01 to 40. Patients will be randomized to active or placebo supplements
      (2:1 ratio, 26 active and 14 placebo) using a randomization table prepared prior to the start
      of the study by a non-participating staff member at the office of the Investigator. The study
      blind will not be broken until the end of the study. All test product and placebo will be
      labeled with subject numbers per the non-participating staff member. Subjects will be
      assigned a subject number in numerical order as enrolled. Randomization will occur by
      assignment to either NUTRAFOL® supplement or placebo with 2:1 ratio (26 active and 14
      placebo). Subjects who terminate their study participation for any reason, regardless of
      whether study medication was used or not, will retain their randomization number.

      Visit Procedures: Pre-Study Procedures

        1. Candidate subjects will be screened with the eligibility requirements by telephone prior
           to Visit 1.

        2. Candidate subjects will be assigned an appointment time for visiting the clinic.

      Visit 1: Baseline, Day 0

        1. Individuals will be given an informed consent (IC) document & photographic release form,
           HIPAA form, confidentiality agreement to read. They will have all of their study related
           questions answered by the Investigator or his/her designated staff and if they agree,
           they will sign two copies of the IC/Photography release form, two copies of the HIPAA
           form, and one copy of the confidentiality agreement. Subjects will be given one copy of
           the signed IC/Photography release and of the HIPAA agreement to keep, with one copy of
           each document remaining at the testing facility in the subject's file.

        2. Investigator and/or Study Coordinator will review with subject and complete the
           checklist for all inclusion and exclusion criteria.

        3. Investigator and/or Study Coordinator will review with subject and complete the
           checklist for medical history and concomitant medications.

        4. Investigator and/or Study Coordinator will review with subject and complete the General
           Lifestyle Questionnaire. The General Lifestyle Questionnaire may be found in Appendix
           VI.

        5. Subjects will be given a Women's Hair Loss Quality of Life Questionnaire to read and
           complete. The Quality of Life Questionnaire may be found in Appendix VII.

        6. Candidate subjects will receive a brief physical exam, including examination of the
           scalp, to rule out any immediately observable medical issues and any scalp
           alopecias/scalp disorders that are unacceptable for qualification. The physical will
           additionally include vital signs (pulse and blood pressure), weight and height.

        7. Candidate subjects of childbearing potential will complete a urine pregnancy test prior
           to product distribution.

        8. Candidate subjects who have completed all the initial paperwork and meet the
           inclusion/exclusion qualifications (to include findings of the physical exam) will be
           assigned a unique subject number. Subjects will be randomized to treatment group prior
           to dispensing the test product.

        9. Qualified subjects will have 2D digital photography of the entire head/hair region for
           overall general hair growth and fullness (see Appendix I).

       10. Qualified subjects will have their scalp prepared for digital macrophotography and
           initial target area measurements done (see Appendix II).

       11. Subjects will have the selected target area (1cm x 1cm) photographed (see Appendix II).

       12. Subjects will have the extended target area (2cm x 2cm) bundle of hair measured for Hair
           Mass Index (HMI) (see Appendix III).

       13. Subjects will have ten (10) terminal hairs in a selected test site cut at the base of
           the scalp and the diameter of the hairs measured (see Appendix IV).

       14. Subjects will be dispensed a three (3) month supply of the test product (NUTRAFOL®
           supplement or Placebo, as randomized) and given written and verbal Usage and Lifestyle
           instructions (see Appendix X) and a calendar of future visits. Subjects will be
           instructed to ingest the test product per Sponsor instructions.

      Usage Instructions:

      Take 4 capsules once daily, along with a meal or immediately following (within 5 minuntes) at
      approximately the same time of the day, every day. Do not take on an empty stomach. If you
      forgot to take your dose during a meal, do not skip the dose, take it with something fatty,
      like peanut butter or coconut oil when you remember. Store at room temperature, in a cool dry
      location. Do not take if broken or seal is compromised.

      Subjects will be instructed to return all empty bottles and unused test product at Visits 2
      and 3.

      Lifestyle Instructions:

      Subjects will be instructed to maintain their normal hair care routine. Subjects will be
      instructed to use the same brand/type of hair care products and maintain the same haircut,
      color and style for the study duration.

      Subjects who have color treated hair will also be instructed 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).

      Subjects will be instructed to come to each visit with clean and dry hair.

      Subjects will be instructed to use a medically sound form of birth control during the study.

      Visit 2: Month 3 (90 days) ± 1 week (7 days)

        1. A clinician will ask subjects if they have experienced any changes in their health or
           taken new/adjusted current medications since the last visit. If an AE or SAE is
           reported, the examining Investigator will be informed and the appropriate forms will be
           completed.

        2. The test product will be collected and counted for compliance. Subjects found to be
           consistently out of compliance will be reminded of the correct usage instructions.

        3. Subjects will receive a brief physical exam. The physical will include vital signs
           (pulse and blood pressure).

        4. Subjects will complete the Women's Hair Loss Quality of Life Questionnaire (see Appendix
           VII), the Self-Assessment Questionnaire (see Appendix VIII) and the Subject Treatment
           Satisfaction and Ease of Use Questionnaire (see Appendix IX).

        5. Subjects will have their hair assessed by the Blinded Investigator for Hair Growth and
           Hair Quality (see Appendix V).

        6. Subjects will have 2D digital photography of the entire head/hair region for overall
           general hair growth and fullness ( see Appendix I).

        7. Subjects will have their scalp prepared for digital macrophotography and target area
           measurements done (see Appendix II).

        8. Subjects will have the selected target area (1cm x 1cm) photographed (see Appendix II).

        9. Subjects will have the extended target area (2cm x 2cm) bundle of hair measured for Hair
           Mass Index (HMI) (see Appendix III).

       10. Subjects will have ten (10) terminal hairs in a selected test site cut at the base of
           the scalp and the diameter of the hairs measured (see Appendix IV).

       11. Subjects will be dispensed a three (3) month supply of the test product (NUTRAFOL®
           supplement or Placebo, as randomized) and given written and verbal Usage and Lifestyle
           instructions (see Appendix X) and a calendar of future visits. Subjects will be
           instructed to ingest the test product per Sponsor instructions.

      Visit 3: Month 6 (180 days) ± 1 week (7 days)

        1. A clinician will ask subjects if they have experienced any changes in their health or
           taken new/adjusted current medications since the last visit. If an AE or SAE is
           reported, the examining Investigator will be informed and the appropriate forms will be
           completed.

        2. The test product will be collected and counted.

        3. Subjects will receive a brief physical exam. The physical will include vital signs
           (pulse and blood pressure).

        4. Subjects will complete the Women's Hair Loss Quality of Life Questionnaire (see Appendix
           VII), the Self-Assessment Questionnaire (see Appendix VIII) and the Subject Treatment
           Satisfaction and Ease of Use Questionnaire (see Appendix IX).

        5. Subjects will have their hair assessed by the Blinded Investigator for Hair Growth and
           Hair Quality (see Appendix V).

        6. Subjects will have 2D digital photography of the entire head/hair region for overall
           general hair growth and fullness (see Appendix I).

        7. Subjects will have their scalp prepared for digital macrophotography and target area
           measurements done (see Appendix II).

        8. Subjects will have the selected target area (1cm x 1cm) photographed (see Appendix II).

        9. Subjects will have the extended target area (2cm x 2cm) bundle of hair measured for Hair
           Mass Index (HMI) (see Appendix III).

       10. Subjects will have ten (10) terminal hairs in a selected test site cut at the base of
           the scalp and the diameter of the hairs measured (see Appendix IV).

      All primary and secondary parameters will be collected at Visits 1, 2 and 3. Missing data
      values will be minimized by intensive training of the interviewers in techniques of
      clarifying answers and checking questionnaires while participants are on-site. When missing
      values are identified, several approaches such as rescheduled within 24 hours of completion
      of tests or interviews will be employed to acquire the necessary data. Missing data will be
      also examined to assess randomness. Descriptive statistics will be obtained for all
      variables, tests of normality of continuous measures will be made and data will be examined
      for homogeneity of variance. An appropriate statistical method will be employed to correct
      for any abnormalities. The comparability of the two treatment groups in baseline demographic
      and clinical features will be tested with analyses of variance (ANOVAs) for continuous
      variables and Chi-square analyses for dichotomous variables. Initially, groups will be
      compared across all three visits for overall interaction effect. For any outcome with
      significant two-way interaction, group differences from baseline Visit to other two visits
      will be tested using analyses of variance with repeated measurements. These analyses were
      performed using the SPSS version 19. All analyses were two-tailed, where applicable, with
      p-value of 0.05 or less is obtained but other p-values may be evaluated on a case-by-case
      basis
    

Intervention name(s): Nutrafol Supplement capsules; Placebo capsules
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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.; The placebo capsules contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial meal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hair thinning, Hair loss, Women, Nutraceutical supplement