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

NCT06571799 | Completed

• 1 other identifier: BNV-EXO-HAIR-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Thinning Hair

Outcome Measures

Primary Outcomes (3)

• Change in Terminal Hair Counts

  Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of 40 micrometers. This is calculated by the Canfield HairMetrix System.

  Baseline to Day 120 or End of Study Visit

• Change in Vellus Hair Counts

  Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers. This is calculated by the Canfield HairMetrix System.

  Baseline to Day 120 or End of Study Visit

• Change in Total Hair Counts

  Total hairs equals the sum of Terminal and Vellus hairs in the target area. This is calculated by the Canfield HairMetrix System.

  Baseline to Day 120 or End of Study Visit

Secondary Outcomes (10)

• Change in Terminal to Vellus Hair Count Ratio

  Baseline to Day 120 or End of Study Visit

• Change in average hairs per follicular unit

  Baseline to Day 120 or End of Study Visit

• Change in average hair width

  Baseline to Day 120 or End of Study Visit

• Change in follicular hair units per cm2

  Baseline to Day 120 or End of Study Visit

• Change in inter-follicular hair mean distance

  Baseline to Day 120 or End of Study Visit

Other Outcomes (3)

• Frequency of both local and systemic Adverse Events

  Baseline to Day 120 or End of Study Visit

• Changes in Clinical laboratory analyses of Complete Blood Count without Differential and with Platelets

  Baseline to Day 120 or End of Study Visit

• Change in Clinical laboratory analyses of Complete Metabolic Panel

  Baseline to Day 120 or End of Study Visit

Study Arms (1)

BENEV Exosome Regenerative Complex+

OTHER

BENEV Exosome Regenerative Complex+® post SylFirmX® RF microneedling procedure applied to the scalp monthly for 4 sessions.

Other: BENEV Exosome Regenerative Complex+

Interventions

BENEV Exosome Regenerative Complex+ OTHER

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.

BENEV Exosome Regenerative Complex+

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects meeting all of the following criteria will be eligible for study entry:
• Healthy males and females of all Fitzpatrick Skin Types between 18 and 65 years of age.
• 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.
• Subjects must be in general good health, as determined by the Investigator.
• Subjects with self-perceived hair thinning as determined on initial study assessment by the Investigator (excluding patients with medically diagnosed telogen effluvium).
• 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.
• 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.
• 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.
• FOCBP must have a negative urine pregnancy test at the Baseline Visit.
• Subjects willing to give a blood sample collected for routine laboratory analysis (Complete Blood Count and Comprehensive Metabolic Panel).
• 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.
• Subjects willing to have digital trichoscopy photography of the target site areas on the scalp for analysis of hair counts and other hair measurements.
• Subjects willing to have RF microneedling procedure of the scalp region followed by application of IP.
• Subjects must be willing and able to complete and understand the rating questionnaires.
• Subjects must maintain a consistent length, cut, style and color throughout the four (4) month study period.

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded from the study:
• Subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
• Subjects who have had a hair transplant.
• Subjects with any known allergy or sensitivity to any shampoo and/or conditioner.
• Subjects with known stressful incident within the last six months (e.g. death in family, miscarriage).
• 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.
• Subjects using Low Level Laser Therapy (LLLT) or other light therapy to treat thinning hair in the last 3 months.
• Subjects who have regularly used Rogaine (Minoxidil), Nioxin and /or Finasteride or undergone any other hair or scalp treatments within the last 3 months.
• 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).
• 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.
• 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.
• 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.
• Subjects with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.
• 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.
• Subjects who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.

Sponsors & Collaborators

• Ablon Skin Institute Research Center: lead
• Benev Company, Inc.: collaborator

Study Sites (1)

Ablon Skin Institute & Research Center

Manhattan Beach, California, 90266, United States

Location

Related Publications (1)

• Ablon G. An Exosome Regenerative Complex Plus Microneedling Promotes Hair Growth in Subjects With Self-Perceived Thinning Hair. J Drugs Dermatol. 2025 Oct 1;24(10):988-994. doi: 10.36849/JDD.9244.

  PMID: 41037530 DERIVED

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open label study evaluating the efficacy and safety
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label study evaluating the efficacy and safety

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 26, 2024
• Study Start: September 3, 2024
• Primary Completion: February 27, 2025
• Study Completion: March 27, 2025
• Last Updated: April 6, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)