Hair Thinning Clinical Trial
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
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.
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
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT05019066 -
Oral Herbal Combination Formulation and Hair Growth in Women
|
N/A | |
Completed |
NCT05800496 -
A Clinical Study to Assess the Safety and Effectiveness of Plant Based Biotin in Healthy Human Subjects With Thin, Dry, and Brittle Hair
|
N/A | |
Terminated |
NCT03709563 -
Oral Nutraceutical Supplement With Standardized Botanicals in Males With Self-Perceived Thinning Hair and Loss
|
N/A | |
Recruiting |
NCT06376409 -
Prospective Study of Nutraceutical Supplements to Support Hair Growth in Females
|
N/A | |
Recruiting |
NCT06362941 -
Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men
|
N/A | |
Completed |
NCT05332743 -
Nutraceutical Supplement With Vegan Botanicals in Females With Self-Perceived Thinning Hair
|
N/A | |
Recruiting |
NCT04048031 -
Efficacy and Safety of a Nutraceutical Supplement With Standardized Botanicals in Peri-menopausal and Menopausal Women With Thinning Hair
|
N/A | |
Completed |
NCT05339958 -
Nutraceutical Supplement With Standardized Botanicals in Males With Thinning Hair
|
N/A | |
Enrolling by invitation |
NCT06174441 -
The Effect of 24-week Dietary Intake of Food Supplements on Hair
|
N/A | |
Recruiting |
NCT06146166 -
The Effects of an Oral Hair Supplement on Hair Density, Growth, and Microbiome
|
N/A | |
Completed |
NCT02302053 -
Efficacy of the New Viviscal Professional Strength Oral Supplement in Females With Thinning Hair
|
N/A | |
Active, not recruiting |
NCT06060834 -
Impact of a Topical Cosmetic Product on Women's Hair
|
N/A | |
Completed |
NCT02297360 -
Viviscal Extra-Strength Formulation To Promote Hair Growth And Decrease Shedding In Women With Thinning Hair
|
N/A | |
Recruiting |
NCT06010745 -
Effectiveness of a Novel Dietary Ingredient on Hair Growth and Skin's Appearance
|
N/A | |
Completed |
NCT04450602 -
A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Female Subjects With Hair Loss
|
N/A | |
Completed |
NCT02288858 -
To Evaluate the Effects of Viviscal Oral Supplements When Used by Females With Self-perceived Thinning Hair
|
N/A | |
Completed |
NCT04450589 -
A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Male Subjects With Hair Loss
|
N/A |