| Eligibility |
Inclusion Criteria:
1. Females of all Fitzpatrick skin, and hair types between 18-50 years of age with
self-perceived thinning, confirmed by a dermatologist.
2. Females leading a more plant-based lifestyle as of the last 3 months or longer
according to the following categories: Vegetarian, Lacto-vegetarian, Ovo-Vegetarian,
Lacto-ovo Vegetarian, Vegan, Raw Vegan, Pescatarian, Pollotarian,
Flexitarian/Semi-Vegetarian
3. Willing and able to adhere to the same dietary lifestyles for the duration of the
study
4. Able to understand and sign an informed consent agreement and photo release form
approved by the Institutional Review Board
5. General good health, as determined by the Investigator or qualified sub-investigator
6. Willing and able to attend all study visits and comply with the test product daily
instructions.
7. Willing to maintain the same hair length, hairstyle, and coloring practices for the
duration of the study. Subjects who have color-treated hair must have the color
treatment performed at the same time interval prior to each visit.
8. Willing to use a mild non-medicated shampoo and conditioner for the duration of the
study (medicated shampoo and conditioner refer to any prescription shampoo or
conditioner as well as any over-the counter medicated shampoo or conditioner, such as
those for treatment of dandruff or promoting hair growth).
9. Willing and able to cooperate with the requirements of the study.
10. Able to complete and understand the various rating instruments.
Exclusion Criteria:
1. Individuals who are pregnant, planning a pregnancy, nursing, or within 1-year
post-partum.
2. Individuals who have experienced serious complications due to COVID-19 previously or
during the study as determined by the investigator.
3. Clinical diagnosis of hair loss disorder such as alopecia areata, or scarring forms of
alopecia.
4. Individuals who have had a history of any acute or chronic disease that could
interfere with or increase the risk on study participation
5. Individuals who have had a history of any acute or chronic medical or hair condition
that could affect study results, such as a history of disordered eating
6. Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
7. Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun
damage, seborrheic dermatitis), infection, cuts, and/ or abrasions on the scalp or
condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the
Investigator or qualified sub-investigator, might put the subject at risk or interfere
with the study conduct or evaluations.
8. History of surgical correction of hair loss on the scalp (i.e., hair transplant).
9. Use of any products or devices purported to promote scalp hair growth (e.g.,
finasteride or minoxidil) within the 6 months prior to the Baseline Visit.
10. 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).
11. History of burning, flaking, itching, and stinging of the scalp.
12. History of malignancy (except cutaneous squamous cell carcinoma and basal cell
carcinoma) or currently undergoing chemotherapy or radiation treatments.
13. A known history of autoimmune thyroid disease, any other thyroid disorder/abnormality
or other autoimmune disorders that in the opinion of the Investigator or qualified
sub-investigator may interfere with the study treatment.
14. A known history of unstable or chronic depression or bipolar disease or any other
condition that may impact the subject's participation in the opinion of the
investigator or qualified sub-investigator.
15. A known allergy to any of the ingredients in the investigational product.
16. Utilization of low-level lasers for hair growth in the last three months.
17. Any condition that the Investigator thinks may put the subject at risk or interfere
with their participation in the study or study results.
18. Known history or recent blood work indicating iron deficiency, bleeding disorders or
platelet dysfunction syndrome as well as subjects receiving anticoagulant therapy or
smokers with usage >20 cigarettes/day.
19. Use of any medications or medicated shampoos that are known to potentially cause hair
loss or affect hair growth, as determined by the Investigator or qualified
sub-investigator.
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