Efficacy and Safety of TargetCool + Benev Exosomes in Patients With Hair Thinning

March 5, 2026 updated by: Recens Medical, Inc.

A Prospective, 8-Month, Randomized Pilot Study of TargetCool™ Cryo-Modulation and BENEV Exosome Regenerative Complex+® for Hair Density Enhancement in Adults With Non-Scarring Hair Thinning

This clinical trial is testing a new approach to help improve hair thinning using a combination of cosmetic treatments. The purpose of the study is to learn whether applying exosomes to the scalp, along with microneedling and a precision cooling device called TargetCool™. This study aims to determine whether this combination approach offers synergistic benefits for individuals with hair thinning.

Exosomes are tiny particles that come from stem cells and contain growth factors and other nutrients. They are being studied for their potential to help regenerate skin and hair. TargetCool™ is an FDA-cleared device that uses precision cooling to reduce inflammation and improve comfort. Microneedling is a common, minimally invasive procedure that uses small needles to stimulate the skin and help absorb topical products more effectively.

The study will include healthy men (ages 18 to 70) and women (ages approximately 45 to 70) who are not of childbearing potential. A total of 9 to 15 participants will be randomly placed into one of three groups:

Group 1: Exosomes with TargetCool™ Group 2: Microneedling followed by exosomes and TargetCool™ Group 3: Microneedling followed by exosomes only Participants will receive four treatments over 9 weeks. Each visit may include microneedling, TargetCool™ treatment, and exosome application depending on group assignment. A small tattoo will be placed on the scalp to help capture consistent photographs, and a special imaging system (Canfield HairMetrix®) will be used to measure hair changes.

Participants will return for follow-up visits at 3 and 6 months after the final treatment. The results will help determine whether this combination of cosmetic treatments is safe and beneficial for people experiencing hair thinning.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Marc Avram MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Healthy males between 18-70 years of age and females not of child-bearing age 45-70 years of age of all Fitzpatrick Skin Types.
  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 hair thinning as determined on initial study assessment by the Investigator.
  5. Patients are not on medical treatment or have been on stable treatment for >12 months (eg. minoxidil, finasteride, dutasteride, PRP, LLLT)
  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. Subjects willing to have Canfield digital photography of the entire head/hair region for overall evaluation of general hair growth and quality by the Investigator.
  8. Subjects willing to have TargetCool boosting or microneedling of the scalp region with or followers by application of exosomes.
  9. Subjects must be willing and able to complete and understand the rating questionnaires.
  10. Subjects must be willing and able to attend all study visits and comply with the post procedure and lifestyle instructions

Exclusion Criteria:

  1. Subjects who are of child-bearing age, 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 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.
  4. Subjects who started any new hair loss treatment in the last 12 months.
  5. 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 12 months, cyproterone acetate, aldactone/spironolactone or any 5-alpha-reductase inhibitor).
  6. 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 12 months.
  7. Subjects suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, and telogen effluvium as determined during initial study assessment and physical exam by the Investigator.
  8. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TargetCool with Benev exosome Boost
Device: Scalp tattoo
A micropigmentation scalp tattoo will be applied at baseline to mark consistent photographic sites.
Device: Canfield HairMetrix®
Canfield HairMetrix® imaging will be utilized to capture global and trichoscopic hair measurements.
Device: TargetCool
Boosting will be used to apply exosomes
Active Comparator: Microneedling followed by TargetCool Boosting with Benev exosome
Device: Scalp tattoo
A micropigmentation scalp tattoo will be applied at baseline to mark consistent photographic sites.
Device: Canfield HairMetrix®
Canfield HairMetrix® imaging will be utilized to capture global and trichoscopic hair measurements.
Device: TargetCool
Boosting will be used to apply exosomes
Device: Microneedle-facilitated lidocaine application
Microneedling will be performed to a depth of 0.5 mm.
Active Comparator: Microneedling to depth of 0.5mm followed by Benev exosome topical
Device: Scalp tattoo
A micropigmentation scalp tattoo will be applied at baseline to mark consistent photographic sites.
Device: Canfield HairMetrix®
Canfield HairMetrix® imaging will be utilized to capture global and trichoscopic hair measurements.
Device: Microneedle-facilitated lidocaine application
Microneedling will be performed to a depth of 0.5 mm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Terminal Hair Counts
Time Frame: 32 weeks (8 months)
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.
32 weeks (8 months)
Change in Vellus Hair Counts
Time Frame: 32 weeks (8 months)
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.
32 weeks (8 months)
Change in Total Hair Counts
Time Frame: 32 weeks (8 months)
Total hairs equals the sum of Terminal and Vellus hairs in the target area. This is calculated by the Canfield HairMetrix System.
32 weeks (8 months)
Change in average hair width
Time Frame: 32 weeks (8 months)
This is the average hair width calculated in micrometers by the Canfield HairMetrix System.
32 weeks (8 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Investigator Hair Growth Global Improvement Scale
Time Frame: 32 weeks (8 months)

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 delineated visits as indicated in the schedule of events, compared to baseline. The Investigator will complete this assessment at the end of study. 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
32 weeks (8 months)
Change in Subject Hair Self-Assessment Questionnaire scores
Time Frame: 32 weeks (8 months)

Overall hair appearance:

  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
32 weeks (8 months)
Change in Hair Treatment Subject Satisfaction Questionnaire scores
Time Frame: 32 weeks (8 months)
  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
32 weeks (8 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of both local and systemic Adverse Events
Time Frame: 32 weeks (8 months)
An adverse event is any adverse change from the subject's baseline condition, i.e. any subjective signs and symptoms, or change in a concomitant disease present at the screening visit. This includes inter-current signs, symptoms, illness and significant deviations from baseline which may occur during the course of the clinical study, whether considered related to treatment or not.
32 weeks (8 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recens Medical, Inc.

Collaborators

Benev Company, Inc.

Investigators

  • Principal Investigator: Marc Avram, MD
  • Principal Investigator: Dawn Queen, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

May 14, 2025

First Submitted That Met QC Criteria

May 22, 2025

First Posted (Actual)

May 31, 2025

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-2025-DERM-001-IIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) that underlie the results reported in this study will be shared.

IPD Sharing Time Frame

Beginning 6 months after publication and available for up to 2 years.

IPD Sharing Access Criteria

Requests must include a brief proposal outlining study aims and methodology. The study team will review each request for scientific merit. Data will be shared via secure, password-protected transfer.

Researchers may request access by contacting michele@dravram.com.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe