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Thinning HairNCT06571799

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

A study testing BENEV Exosome Regenerative Complex+ in people with Thinning Hair, run by Ablon Skin Institute Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Thinning Hair
What is being tested?
BENEV Exosome Regenerative Complex+
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
3 Sep 2024to 27 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Subjects who have color treated hair must be willing to have the color treatment performed at the same time interval prior to visits.
  • 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).
  • Subjects must be willing and able to attend all study visits and comply with the post procedure and lifestyle instructions.

Who cannot join

  • 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.
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  • 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.
  • Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ablon Skin Institute & Research Center

    Manhattan Beach, California, 90266

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Thinning Hair
Being tested
BENEV Exosome Regenerative Complex+
Medical subject headings
Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06571799
Study groupRoleWhat they receive
BENEV Exosome Regenerative Complex+OtherBENEV Exosome Regenerative Complex+® post SylFirmX® RF microneedling procedure applied to the scalp monthly for 4 sessions.
Receives: Other: BENEV Exosome Regenerative Complex+

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Day 120 or End of Study Visit

  2. 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.

    Measured: Baseline to Day 120 or End of Study Visit

  3. 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.

    Measured: Baseline to Day 120 or End of Study Visit

Secondary outcomes (10)

  1. Change in Terminal to Vellus Hair Count Ratio

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

    Measured: Baseline to Day 120 or End of Study Visit

  2. Change in average hairs per follicular unit

    This is the average number of hairs measured in each follicular unit.This is calculated by the Canfield HairMetrix System.

    Measured: Baseline to Day 120 or End of Study Visit

  3. Change in average hair width

    This is the average hair width calculated in micrometers by the Canfield HairMetrix System.

    Measured: Baseline to Day 120 or End of Study Visit

  4. Change in follicular hair units per cm2

    This is the number of follicles per cm2 measured by the Canfield HairMetrix System.

    Measured: Baseline to Day 120 or End of Study Visit

  5. Change in inter-follicular hair mean distance

    This is the distance between hair follicles measured in millimeters by theCanfield HairMetrix System.

    Measured: Baseline to Day 120 or End of Study Visit

  6. Change in Investigator Hair Growth Global Improvement Scale

    The treating Investigator will complete this assessment by circling the number on the scale that corresponds to the description that best fits the current global growth improvement at delinated visits as indicated in the schedule of events, compared to baseline. The Investigator will complete this assessment during the study at Visits 2, 3, 4 and 5. The Investigator must complete this assessment using global photographs obtained compared to baseline. In addition, the Investigator may use their clinical judgment from the in-person visit.

    • 3 Greatly worsened
    • 2 Moderately worsened
    • 1 Slightly worsened 0 No change
    • 1 Slightly improved
    • 2 Moderately improved
    • 3 Greatly improved

    Measured: Baseline to Day 120 or End of Study Visit

  7. Change in Investigator Hair Quality Global Improvement Scale

    The treating Investigator will complete this assessment by circling the number on the scale that corresponds to the description that best fits the current hair quality at delinated visits as indicated in the schedule of events, as compared to the subject's hair quality at baseline. Assessment grading is to be based upon the Investigator's appraisal of hair brittleness, dryness, texture, shine, scalp coverage and overall appearance. The Investigator will complete this assessment during the study at Visits 2, 3, 4 and 5. The Investigator must complete this assessment using global photographs obtained compared to baseline. In addition, the Investigator may use their clinical judgment from the in-person visit.

    • 3 Greatly worsened
    • 2 Moderately worsened
    • 1 Slightly worsened 0 No change
    • 1 Slightly improved
    • 2 Moderately improved
    • 3 Greatly improved

    Measured: Baseline to Day 120 or End of Study Visit

  8. Change in Hair Shedding Pull Test scores

    The hair pull test will be performed by the Investigator to evaluate hair shedding. In the hair pull test, gentle traction will be applied on a group of hairs (approximately 60 hairs) from proximal to distal end, in the vertex area, both parietal areas and occipital area of the scalp. The grasp is made with the help of the thumb, index finger and middle finger, ensuring consistent pressure with each pull. If more than 10% (~6 or more) hairs come out with every pull, the test is considered positive. Subjects will be instructed not to shampoo or wash their hair 24 hours prior to the test for accurate results.

    Measured: Baseline to Day 120 or End of Study Visit

  9. Change in Subject Hair Self-Assessment Questionnaire scores

    This scale is used to rate the qualities listed below:

    1. Greatly Decreased/Worsened
    2. Moderately Decreased/Worsened
    3. Slightly Decreased/Worsened
    4. No Change
    5. Slightly Increased/Improved
    6. Moderately Increased/ Improved
    7. Greatly Increased/ Improved

    Overall hair growth Overall hair volume Scalp coverage Hair thickness Hair Fullness Hair quality Hair shine Hair strength Hair softness Amount of noticeable new hair Hair growth rate Hair growth on top of your head (scalp coverge) Hair growth of the hairline (at the front of your head or hairline coverage) Hair length (ability to grow longer than usual) Ease of styling Overall hair appearance Nail Strength Nail Growth Rate Growth of Eyebrow Hair Growth of Eyelashes Skin Smoothness Overall Skin Health

    Measured: Baseline to Day 120 or End of Study Visit

  10. Change in Hair Treatment Subject Satisfaction Questionnaire scores

    1. How satisfied are you with this treatment for your thinning hair? 5 = Very Satisfied 4 = Satisfied 3 = Neutral 2 = Dissatisfied 1 = Very Dissatisfied
    2. How satisfied are you with the overall health of your hair after this treatment? 5 = Very Satisfied 4 = Satisfied 3 = Neutral 2 = Dissatisfied 1 = Very Dissatisfied
    3. Overall, how satisfied are you with the ease of this treatment? 5 = Very Satisfied 4 = Satisfied 3 = Neutral 2 = Dissatisfied 1 = Very Dissatisfied
    4. Overall, now that you have tried this treatment and completed the study, how likely are you to continue the treatment in the future? 5 = Very Likely 4 = Somewhat Likely 3 = Neutral 2 = Somewhat Unlikely 1 = Very Unlikely
    5. Overall, how likely are you to recommend this treatment to a family member or friend? 5 = Very Likely 4 = Somewhat Likely 3 = Neutral 2 = Somewhat Unlikely 1 = Very Unlikely

    Measured: Baseline to Day 120 or End of Study Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start3 Sep 2024
  3. Primary completion27 Feb 2025
  4. Study completion27 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label study evaluating the efficacy and safety
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06571799
Sponsor's protocol ID
BNV-EXO-HAIR-01
Status last verified
Aug 2024
First submitted
23 Aug 2024
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41037530

Questions about this trial

What is this clinical trial studying?

A study testing BENEV Exosome Regenerative Complex+ in people with Thinning Hair, run by Ablon Skin Institute Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Terminal Hair Counts (time frame: Baseline to Day 120 or End of Study Visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06571799, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.

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