Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men

Inclusion Criteria:

1. Female or male subjects with concerns and/or signs of hair thinning.

2. The subjects must meet the age characteristics based on their supplement groupassignment.

3. Subjects are Fitzpatrick Skin Types I to VI.

4. Subjects must be in good general health.

5. Subjects must be classified with thinning hair by the study dermatologist.

6. Willing to maintain the same hair length, hairstyle, and coloring practices for theduration of the study. Subjects who have color-treated hair must have the colortreatment performed at the same time interval prior to each visit.

7. Willing to use a mild non-medicated shampoo and conditioner for the duration of thestudy (medicated shampoo and conditioner refer to any prescription shampoo orconditioner as well as any over-the counter medicated shampoo or conditioner, suchas those for treatment of dandruff or promoting hair growth).

8. Willing and able to adhere to the same dietary lifestyles for the duration of thestudy

9. Subjects must express willingness to cooperate with the investigator and comply tostudy requirements.

10. Subjects must demonstrate the ability to read and understand all the items in theinformed consent document.

11. Subjects must agree not to use any other hair supplements or start a new vitaminsupplement during the study.

12. Subject has signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects."

13. Subject is dependable and able to follow directions and is willing to comply withthe schedule of visits.

Exclusion Criteria:

1. Any previous or current acute or chronic medical or hair condition, which in theinvestigator's opinion, may interfere with the study results or increase the studyparticipation risks to the subject.

2. Subjects possessing signs of severe female or male pattern hair loss or alopecia (including androgenetic and traction alopecia) as determined by the studydermatologist.

3. Scalp hair loss on the treatment area, due to disease, injury, or medical therapy

4. Subjects who are not willing to use only the assigned oral study supplement and nonew oral supplements during the study.

5. Subjects who have demonstrated a previous hypersensitivity reaction to any of theingredients of the study product.

6. Subjects, who are pregnant, breast feeding, or planning a pregnancy.

7. Subjects with clinically significant unstable medical disorders.

8. Subjects who are unwilling or unable to comply with the requirements of theprotocol.

9. Subjects who have history of a psychological illness or condition that wouldinterfere with their ability to understand and/or follow the requirements of thestudy.

10. Subjects with any planned surgeries and/or invasive medical procedures during thecourse of the study.

11. History of surgical correction of hair loss on the scalp (i.e., hair transplant).

12. 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.

13. Females who have recently (within the last 6 months) started the use of hormones forbirth control or hormone replacement therapy (HRT). Women currently using Scalp hairloss on the treatment area, due to disease, injury, or medical therapy

14. hormones for birth control or HRT must have been on a stable dose (6 months orlonger) in order to be eligible for the study (the initiation of HRT or birthcontrol should not have been associated with the initiation of hair loss/thinning).

15. History of burning, flaking, itching, and stinging of the scalp.

16. Utilization of low-level lasers for hair growth in the last three months.

17. Known history or recent blood work indicating iron deficiency, bleeding disorders orplatelet dysfunction syndrome as well as subjects receiving anticoagulant therapy orsmokers with usage >20 cigarettes/day.

18. Use of any medications or medicated shampoos that are known to potentially causehair loss or affect hair growth, as determined by the Investigator or qualifiedsub-investigator.