A Safety and Efficacy Study of a Nutraceutical in Aging Males with Thinning Hair

Inclusion Criteria:

1. Male, 40 to 65 years of age.

2. In good general health (physical, mental, and social well-being, not merely theabsence of disease/infirmity), according to subject self-report.

3. Having Fitzpatrick skin type I-IV.

4. Having overall hair thinning (diffuse thinning of the top of the crown or at templesand/or widening part or receding hair line) confirmed by the study dermatologist atbaseline (grade III, IIIa, III vertex, IV, or IVa on the Hamilton-Norwood scale).

5. With self-perceived thinning hair on the scalp.

6. Willing to participate in the Hair Pull Test, in which a trained practitioner willgrasp a 4-6mm bundle of hair near the scalp and firmly tug the hair.

7. Having a regular mild, non-medicated shampoo and conditioner (if used) and willingto bring the product(s) in to the first clinic visit for documentation and tocontinue using the product(s) for the duration of the study.

8. Willing to continue using regularly used hair styling products (mousse, hairspray)if used, and not start using any new hair products for the duration of the study.

9. Willing to maintain the same hair length, hairstyle, and coloring practices for theduration of the study. Those with color-treated hair must have the color treatmentperformed at the same time interval prior to each visit.

10. Willing to maintain current diet (eg, amount, type, and frequency of food and drinkconsumed).

11. Willing to not wear hats, scarves, or other head coverings on your head during eachstudy visit.

12. Willing to refrain from using any topical hair products or treatments on the hairthat could affect hair properties (eg, heat treatments, hair relaxers, permanentwave, medicated shampoo, etc) for the duration of the study except for the testmaterial and regular shampoo and conditioner (if used) and styling products.

13. Willing to refrain from hair extensions, tight braids, or hair weaves for theduration of the study.

14. Willing to refrain from taking any vitamins, minerals, or herbal supplements withclaims related to hair growth or benefits during the study, and to not start takingany new vitamins, minerals, or supplements of any kind during the study.

15. Willing to avoid using prescription or over-the-counter (OTC) products designed toor claiming to significantly impact hair loss and/or hair growth for the duration ofthe study.

16. Willing to complete a questionnaire regarding sexual experiences (commonly used inclinical trials to assess sexual functioning).

17. Willing to provide written informed consent and able to read, speak, write, andunderstand English.

18. Willing to sign a photography release.

19. Willing to cooperate and participate by following study requirements for theduration of the study and to report any changes in health status or medications, AEsymptoms, or reactions immediately.

Exclusion Criteria:

1. Having a pregnant partner or a partner that is planning to become pregnant duringthe study.

2. Having a known allergy to any ingredients in the test products.

3. Having a history of skin cancer within the past 5 years.

4. Having hair extensions, hair weave, tight braids, crew cut, or very short hair (lessthan 1.5 inches in length).

5. Having started any new vitamin, mineral, or herbal supplement within 30 days priorto baseline.

6. Smokers with usage >20 cigarettes/day.

7. Who have been diagnosed with hair loss disorders such as alopecia areata, scarringalopecia, traction alopecia, chemical alopecia, trichotillomania or trichorrhexisnodosa, or suffering from moderate to severe hair loss disorder (grade V-VII on theHamilton-Norwood scale) confirmed by the investigator.

8. Having hair loss due to disease, injury, or medical therapy.

9. Who have a history of hair transplants or surgical procedures to the head that mayhave impacted skin anatomy (eg, flaps, grafts, plugs).

10. Who have very brittle or severely damaged hair from causes including chemicaltreatments and excessive tension on the hair (from, eg, tight ponytails or hairextensions).

11. Having a history of persistent burning, itching, or stinging of the scalp.

12. Having clinically active bacterial, fungal, or viral skin infections or those whohave a history of skin infections, according to subject self-report.

13. Who are currently using, planning to use, or have used laser/light therapy (such asHairMax, iRestore), microneedling or scalp micropigmentation, or used anyprescription or over-the-counter (OTC) products designed to or claiming tosignificantly impact hair loss and/or hair growth (eg, minoxidil, Rogaine,finasteride, Propecia, Nioxin shampoo, or oral supplements (such as Biotin >500mcgor Nutrafol)) within 6 months of study start.

14. Having not used any prescription or over-the-counter (OTC) products designed to orclaiming to significantly impact hair loss and/or hair growth (eg, minoxidil,Rogaine, finasteride, Propecia, Nioxin shampoo, or oral supplements (such as Biotin >500mcg or Nutrafol) for at least 6 months prior to baseline, and willing to avoidall such products for the duration of the study.

15. Who are currently using, planning to use, or have used anabolic-androgenic steroids (testosterones) or anti-androgen medication (such as spironolactone, flutamide,cyproterone acetate, cimetidine) other than oral contraceptives; platelet-richplasma (PRP) injections; or tamoxifen within 3 months of study start. (Men currentlyundergoing hormone/testosterone replacement therapy [TRT] can be eligible for thestudy if they have maintained a stable dose for at least 6 months prior toenrollment and stay on the same dose throughout the study.)

16. Having started blood pressure medications or aldactone within 3 months ofenrollment.

17. Having a health condition and/or pre-existing or dormant dermatologic disease on thescalp (eg, excessive dandruff, psoriasis, eczema, seborrheic dermatitis, severeexcoriations) that the Investigator or designee deems inappropriate forparticipation or could interfere with the outcome of the study.

18. Having observable sunburn, suntan, scars, nevi, tattoos, or other dermal conditionson the scalp that might influence the test results in the opinion of theInvestigator or designee.

19. Having a history of immunosuppression/immune deficiency disorders (including HIVinfection, AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis), organtransplant (heart, kidney, etc), or currently using oral or systemicimmunosuppressive medications and biologics (eg, azathioprine, belimumab, Cimzia,Cosentyx, cyclophosphamide, cyclosporine, Enbrel, Humira, Imuran, Kineret,mycophenolate mofetil, methotrexate, Orencia, prednisone, Remicade, Rituxan, Siliq,Simponi, Stelara, Taltz) and/or undergoing radiation or chemotherapy as determinedby study documentation.

20. Currently using or having regularly used corticosteroids (systemic or topical, notnasal or ocular) within the past 4 weeks (including but not limited tobetamethasone, clobetasol, desoximetasone, diflorasone, fluocinonide, halcinonide,and halobetasol).

21. Having a disease such as asthma, diabetes, epilepsy, hypertension, hyperthyroidism,or hypothyroidism that is not controlled by diet or medication. Individuals havingmultiple health conditions may be excluded from participation even if the conditionsare controlled by diet, medication, etc.

22. Having started a long-term medication within the last 2 months.

23. Having any planned surgeries or invasive medical procedures during the study.Noninvasive medical procedures or surgeries will be reviewed for their impact on thestudy outcome and acceptability by the Investigator or designee.

24. Currently participating in any other clinical trial at SGS or another researchfacility or doctor's office.

25. Having a history of unstable, not controlled, or chronic depression or bipolardisease or any other disorder that may impact the participation in the study,according to subject self-report.

26. Having a self-reported history of recent blood work indicating iron deficiency,bleeding disorders, or platelet dysfunction syndrome or currently receivinganticoagulant therapy.

27. Having participated in any clinical trial involving the scalp and/or hair within 2weeks before study enrollment at SGS or another research facility or doctor'soffice.