Study Evaluating the Efficacy and Safety of BENEV Exosome Regenerative Complex+ for Self-perceived Thinning Hair

Inclusion Criteria

• •Subjects meeting all of the following criteria will be eligible for study entry:
• •1. Healthy males and females of all Fitzpatrick Skin Types between 18 and 65 years of age.
• •2. Subjects must be willing to provide verbal understanding and sign an Informed Consent Form, HIPAA Form and Photography Release Form approved by the Institutional Review Board.
• •3. Subjects must be in general good health, as determined by the Investigator.
• •4. Subjects with self-perceived hair thinning as determined on initial study assessment by the Investigator (excluding patients with medically diagnosed telogen effluvium).
• •5. Subjects willing to undergo a brief physical exam to include height, weight, blood pressure, pulse, physical scalp exam and basic systems evaluation (Skin, Respiratory, Cardiovascular, Gastrointestinal, Endocrine, Neurological and Musculoskeletal systems) by the Investigator.
• •6. Subjects willing to not substantially change their current diet, medications, or exercise routines for the duration of the study. If a subject receives physician guidance during the study to change diet, medications, or exercise routine, the subject will need to notify the clinic as soon as possible.
• •7. Females of child bearing potential (FOCBP) must be willing to have a urine pregnancy test and practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months as of the start of the study, intrauterine device, condom with spermicide, diaphragm with spermicide, implant, NuvaRing®, injection, transdermal patch or abstinence.) Females on birth control pills must have taken the same type of pill for at least 3 months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least 3 months prior to the start of the study. The initiation of birth control should not have been associated with the initiation of hair loss/thinning.
• •8. FOCBP must have a negative urine pregnancy test at the Baseline Visit.
• •9. Subjects willing to give a blood sample collected for routine laboratory analysis (Complete Blood Count and Comprehensive Metabolic Panel).
• •10. Subjects willing to have 2-D digital photography of the entire head/hair region for overall evaluation of general hair growth and quality by the Investigator.
• •11. Subjects willing to have digital trichoscopy photography of the target site areas on the scalp for analysis of hair counts and other hair measurements.
• •12. Subjects willing to have RF microneedling procedure of the scalp region followed by application of IP.
• •13. Subjects must be willing and able to complete and understand the rating questionnaires.
• •14. Subjects must maintain a consistent length, cut, style and color throughout the four (4) month study period.
• •15. Subjects who have color treated hair must be willing to have the color treatment performed at the same time interval prior to visits.
• •16. Subjects willing to maintain their normal hair shampooing frequency, use a mild non-medicated shampoo and conditioner for the duration of the study and attend visits with clean and dry hair (shampoo must be done 24 hours or more prior to the visit).
• •17. Subjects must be willing and able to attend all study visits and comply with the post procedure and lifestyle instructions.