Study Evaluating the Efficacy and Safety of BENEV Exosome Regenerative Complex+ for Self-perceived Thinning Hair
- Conditions
- Thinning Hair
- Registration Number
- NCT06571799
- Lead Sponsor
- Ablon Skin Institute Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria<br><br>Subjects meeting all of the following criteria will be eligible for study entry:<br><br> 1. Healthy males and females of all Fitzpatrick Skin Types between 18 and 65 years of<br> age.<br><br> 2. Subjects must be willing to provide verbal understanding and sign an Informed<br> Consent Form, HIPAA Form and Photography Release Form approved by the Institutional<br> Review Board.<br><br> 3. Subjects must be in general good health, as determined by the Investigator.<br><br> 4. Subjects with self-perceived hair thinning as determined on initial study assessment<br> by the Investigator (excluding patients with medically diagnosed telogen effluvium).<br><br> 5. Subjects willing to undergo a brief physical exam to include height, weight, blood<br> pressure, pulse, physical scalp exam and basic systems evaluation (Skin,<br> Respiratory, Cardiovascular, Gastrointestinal, Endocrine, Neurological and<br> Musculoskeletal systems) by the Investigator.<br><br> 6. Subjects willing to not substantially change their current diet, medications, or<br> exercise routines for the duration of the study. If a subject receives physician<br> guidance during the study to change diet, medications, or exercise routine, the<br> subject will need to notify the clinic as soon as possible.<br><br> 7. Females of child bearing potential (FOCBP) must be willing to have a urine pregnancy<br> test and practice effective contraception for the duration of the study. (Effective<br> contraception is defined as stabilized on oral contraceptive for at least 3 months<br> as of the start of the study, intrauterine device, condom with spermicide, diaphragm<br> with spermicide, implant, NuvaRing®, injection, transdermal patch or abstinence.)<br> Females on birth control pills must have taken the same type of pill for at least 3<br> months prior to entering the study and must not change type during the study. Those<br> who have used birth control pills in the past must have discontinued usage at least<br> 3 months prior to the start of the study. The initiation of birth control should not<br> have been associated with the initiation of hair loss/thinning.<br><br> 8. FOCBP must have a negative urine pregnancy test at the Baseline Visit.<br><br> 9. Subjects willing to give a blood sample collected for routine laboratory analysis<br> (Complete Blood Count and Comprehensive Metabolic Panel).<br><br> 10. Subjects willing to have 2-D digital photography of the entire head/hair region for<br> overall evaluation of general hair growth and quality by the Investigator.<br><br> 11. Subjects willing to have digital trichoscopy photography of the target site areas on<br> the scalp for analysis of hair counts and other hair measurements.<br><br> 12. Subjects willing to have RF microneedling procedure of the scalp region followed by<br> application of IP.<br><br> 13. Subjects must be willing and able to complete and understand the rating<br> questionnaires.<br><br> 14. Subjects must maintain a consistent length, cut, style and color throughout the four<br> (4) month study period.<br><br> 15. Subjects who have color treated hair must be willing to have the color treatment<br> performed at the same time interval prior to visits.<br><br> 16. Subjects willing to maintain their normal hair shampooing frequency, use a mild<br> non-medicated shampoo and conditioner for the duration of the study and attend<br> visits with clean and dry hair (shampoo must be done 24 hours or more prior to the<br> visit).<br><br> 17. Subjects must be willing and able to attend all study visits and comply with the<br> post procedure and lifestyle instructions.<br><br>Exclusion Criteria<br><br>Subjects meeting any of the following criteria will be excluded from the study:<br><br> 1. Subjects who are pregnant, nursing mothers, planning a pregnancy during the course<br> of the study, or become pregnant during the study.<br><br> 2. Subjects who have had a hair transplant.<br><br> 3. Subjects with any known allergy or sensitivity to any shampoo and/or conditioner.<br><br> 4. Subjects with known stressful incident within the last six months (e.g. death in<br> family, miscarriage).<br><br> 5. Subjects who have recently (within the last 3 months) started the use of hormones<br> for birth control or hormone replacement therapy (HRT). Women currently using<br> hormones for birth control or HRT must have been on a stable dose (3 months or<br> longer) in order to be eligible for the study.<br><br> 6. Subjects using Low Level Laser Therapy (LLLT) or other light therapy to treat<br> thinning hair in the last 3 months.<br><br> 7. Subjects who have regularly used Rogaine (Minoxidil), Nioxin and /or Finasteride or<br> undergone any other hair or scalp treatments within the last 3 months.<br><br> 8. Subjects who have used prescription drugs known to affect the hair growth cycle<br> within the last 3 months (e.g., hormone-based birth control for less than 3 months,<br> cyproterone acetate, aldactone/spironolactone or any 5-alpha-reductase inhibitor).<br><br> 9. Subjects who have regularly used anti-androgenic therapies (i.e. spironolactone,<br> flutamide, cyproterone acetate, progesterone and/or bicalutamide) or undergone any<br> other hair or scalp treatments within the last 3 months.<br><br> 10. Subjects suffering from other hair loss disorders, such as alopecia areata, scarring<br> alopecia, androgenetic alopecia and telogen effluvium as determined during initial<br> study assessment and physical exam by the Investigator.<br><br> 11. Subjects with self-reported uncontrolled diseases (i.e. diabetes, hypertension,<br> hyperthyroidism, hypothyroidism, etc.). Whether medical conditions are under control<br> with or without treatment will be assessed on an individual basis by the<br> Investigator based on her medical and clinical expertise.<br><br> 12. Subjects with self-reported active hepatitis, immune deficiency, HIV or autoimmune<br> disease.<br><br> 13. Subjects having a known active dermatologic condition of the scalp that may place<br> the subject at a greater risk or interfere with clinical evaluations (ie. seborrheic<br> dermatitis, psoriasis, atopic dermatitis, advanced skin cancer, etc.) as determined<br> by the Investigator based on her medical and clinical expertise.<br><br> 14. Subjects who are unable to communicate or cooperate with the Investigator due to<br> language problems, poor mental development, or impaired cerebral function.<br><br> 15. Subjects with any underlying disease that the Investigator deems uncontrolled, and<br> poses a concern for the subject's safety while participating in the study.<br><br> 16. Subjects with use of any medications that are known to potentially cause hair loss<br> or affect hair growth as determined by the Investigator based on her medical and<br> clinical expertise.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Terminal Hair Counts;Change in Vellus Hair Counts;Change in Total Hair Counts
- Secondary Outcome Measures
Name Time Method Change in Terminal to Vellus Hair Count Ratio;Change in average hairs per follicular unit;Change in average hair width;Change in follicular hair units per cm2;Change in inter-follicular hair mean distance;Change in Investigator Hair Growth Global Improvement Scale;Change in Investigator Hair Quality Global Improvement Scale;Change in Hair Shedding Pull Test scores;Change in Subject Hair Self-Assessment Questionnaire scores;Change in Hair Treatment Subject Satisfaction Questionnaire scores