Clinical trial NCT06571799: Study Evaluating the Efficacy and Safety of BENEV Exosome Regenerative Complex+ for Self-perceived Thinning Hair
Official title: A 4-month, Single Arm Study Evaluating the Efficacy and Safety of BENEV Exosome Regenerative Complex+® Post SylfirmX® RF Microneedling to Promote Hair Growth in Healthy Men and Women With Self-perceived Thinning Hair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thinning Hair
Lead sponsor: Ablon Skin Institute Research Center
Sponsor class: OTHER
Collaborators: name: Benev Company, Inc.
First posted: 2024-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label study evaluating the efficacy and safety
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to further substantiate the effectiveness and safety of BENEV Exosome Regenerative Complex+ post SylFirmX® RF microneedling procedure for self-perceived thinning hair in healthy men and women ages 18-65 over the course of four months. Participants will be asked to have treatments monthly for 4 sessions, attend a follow up appointment 4 weeks after the 4th session, have photos taken of their hair and answer questionnaires related to their thinning hair.

Detailed description: Exosomes represent promising new regenerative medicine treatments for facial rejuvenation and to enhance other cosmetic procedures. Exosomes can provide effective treatment for skin rejuvenation, scar reduction, hyperpigmentation, and hair growth. This new technology can be used alone but are often combined with other older existing aesthetic treatments. Specifically the use of exosomes in hair loss, has been anecdotally observed, but treatment protocols remain elusive and not universally accepted. Since hair loss has a multifactorial etiology, and traditional treatments have limitations, we explore the use of adipose tissue stem cell derived lyophilized exosomes for novel addition to the armamentarium of options to reverse hair thinning or shedding.

Exosome is defined as a 30\~200 nm endoplasmic reticulum that is secreted for cell-to-cell communication and plays an important role in influencing the microenvironment around cells. ExoSCRT™ is an innovative technology to separate and refine 0.1% pure exosomes from stem cells and helps the virtualization of natural skin energy by affecting skin cells effectively. BENEV Exosome Regenerative Complex+® is an intensive dual-action complex formulated to absorb quickly into the skin and scalp delivering the concentrated power of stem cell derived lyophilized exosomes, potent growth factors, peptides, coenzymes, minerals, amino acids and vitamins.

The purpose of this clinical research study is to further evaluate the efficacy and safety of BENEV Exosome Regenerative Complex+® post SylFirmX® RF microneedling procedure of the scalp for self-perceived thinning hair in thirty (30) healthy male and female subjects, ages 18-65 years of age over the course of four (4) months.

Eligibility criteria: 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.

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from the study:

1. Subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
2. Subjects who have had a hair transplant.
3. Subjects with any known allergy or sensitivity to any shampoo and/or conditioner.
4. Subjects with known stressful incident within the last six months (e.g. death in family, miscarriage).
5. Subjects who have recently (within the last 3 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 (3 months or longer) in order to be eligible for the study.
6. Subjects using Low Level Laser Therapy (LLLT) or other light therapy to treat thinning hair in the last 3 months.
7. Subjects who have regularly used Rogaine (Minoxidil), Nioxin and /or Finasteride or undergone any other hair or scalp treatments within the last 3 months.
8. Subjects who have used prescription drugs known to affect the hair growth cycle within the last 3 months (e.g., hormone-based birth control for less than 3 months, cyproterone acetate, aldactone/spironolactone or any 5-alpha-reductase inhibitor).
9. Subjects who have regularly used anti-androgenic therapies (i.e. spironolactone, flutamide, cyproterone acetate, progesterone and/or bicalutamide) or undergone any other hair or scalp treatments within the last 3 months.
10. Subjects suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia and telogen effluvium as determined during initial study assessment and physical exam by the Investigator.
11. Subjects with self-reported uncontrolled diseases (i.e. diabetes, hypertension, hyperthyroidism, hypothyroidism, etc.). Whether medical conditions are under control with or without treatment will be assessed on an individual basis by the Investigator based on her medical and clinical expertise.
12. Subjects with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.
13. Subjects having a known active dermatologic condition of the scalp that may place the subject at a greater risk or interfere with clinical evaluations (ie. seborrheic dermatitis, psoriasis, atopic dermatitis, advanced skin cancer, etc.) as determined by the Investigator based on her medical and clinical expertise.
14. Subjects who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
15. Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.
16. Subjects with use of any medications that are known to potentially cause hair loss or affect hair growth as determined by the Investigator based on her medical and clinical expertise.

Primary outcomes:
measure: Change in Terminal Hair Counts
timeFrame: Baseline to Day 120 or End of Study Visit
measure: Change in Vellus Hair Counts
timeFrame: Baseline to Day 120 or End of Study Visit
measure: Change in Total Hair Counts
timeFrame: Baseline to Day 120 or End of Study Visit
Secondary outcomes:
measure: Change in Terminal to Vellus Hair Count Ratio
timeFrame: Baseline to Day 120 or End of Study Visit
measure: Change in average hairs per follicular unit
timeFrame: Baseline to Day 120 or End of Study Visit
measure: Change in average hair width
timeFrame: Baseline to Day 120 or End of Study Visit
measure: Change in follicular hair units per cm2
timeFrame: Baseline to Day 120 or End of Study Visit
measure: Change in inter-follicular hair mean distance
timeFrame: Baseline to Day 120 or End of Study Visit
measure: Change in Investigator Hair Growth Global Improvement Scale
timeFrame: Baseline to Day 120 or End of Study Visit
measure: Change in Investigator Hair Quality Global Improvement Scale
timeFrame: Baseline to Day 120 or End of Study Visit
measure: Change in Hair Shedding Pull Test scores
timeFrame: Baseline to Day 120 or End of Study Visit
measure: Change in Subject Hair Self-Assessment Questionnaire scores
timeFrame: Baseline to Day 120 or End of Study Visit
measure: Change in Hair Treatment Subject Satisfaction Questionnaire scores
timeFrame: Baseline to Day 120 or End of Study Visit
Other outcomes:
measure: Frequency of both local and systemic Adverse Events
timeFrame: Baseline to Day 120 or End of Study Visit
measure: Changes in Clinical laboratory analyses of Complete Blood Count without Differential and with Platelets
timeFrame: Baseline to Day 120 or End of Study Visit
measure: Change in Clinical laboratory analyses of Complete Metabolic Panel
timeFrame: Baseline to Day 120 or End of Study Visit
Locations:
city: Manhattan Beach
country: United States
facility: Ablon Skin Institute & Research Center
state: California
Study officials:
References: