Hair DiseasesNCT06999408

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

A study testing Scalp tattoo, Canfield HairMetrix® and TargetCool in people with Hair Diseases and Alopecia, run by Recens Medical, Inc. at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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™. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hair Diseases, Alopecia, Hair Thinning
What is being tested?: Scalp tattoo, Canfield HairMetrix® and TargetCool
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 16 Sep 2025to May 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
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 hair thinning as determined on initial study assessment by the Investigator.
Patients are not on medical treatment or have been on stable treatment for >12 months (eg. minoxidil, finasteride, dutasteride, PRP, LLLT)
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.

Show all 10Show fewer

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.
Subjects willing to have TargetCool boosting or microneedling of the scalp region with or followers by application of exosomes.
Subjects must be willing and able to complete and understand the rating questionnaires.
Subjects must be willing and able to attend all study visits and comply with the post procedure and lifestyle instructions

Who cannot join

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.
Subjects who have had a hair transplant.
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 who started any new hair loss treatment in the last 12 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 12 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 12 months.
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.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Marc Avram MD
New York, New York, 10021

Other trials in United States

About this study

Official title: 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

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.

Conditions: Hair Diseases, Alopecia, Hair Thinning
Being tested: Scalp tattoo, Canfield HairMetrix®, TargetCool, Microneedle-facilitated lidocaine application
Keywords: Exosomes, TargetCool, Hair thinning, mirconeedling
Medical subject headings: Hair Diseases, Alopecia

What participants receive

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

Scalp tattooDevice
A micropigmentation scalp tattoo will be applied at baseline to mark consistent photographic sites.
Canfield HairMetrix®Device
Canfield HairMetrix® imaging will be utilized to capture global and trichoscopic hair measurements.
TargetCoolDevice
Boosting will be used to apply exosomes
Microneedle-facilitated lidocaine applicationDevice
Microneedling will be performed to a depth of 0.5 mm.

Study groups in NCT06999408
Study group	Role	What they receive
TargetCool with Benev exosome Boost	Active comparator	Not described Receives: Device: Scalp tattoo; Device: Canfield HairMetrix®; Device: TargetCool
Microneedling followed by TargetCool Boosting with Benev exosome	Active comparator	Not described Receives: Device: Scalp tattoo; Device: Canfield HairMetrix®; Device: TargetCool; Device: Microneedle-facilitated lidocaine application
Microneedling to depth of 0.5mm followed by Benev exosome topical	Active comparator	Not described Receives: Device: Scalp tattoo; Device: Canfield HairMetrix®; Device: Microneedle-facilitated lidocaine application

What is being measured

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

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: 32 weeks (8 months)
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: 32 weeks (8 months)
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: 32 weeks (8 months)
Change in average hair width
This is the average hair width calculated in micrometers by the Canfield HairMetrix System.
Measured: 32 weeks (8 months)

Secondary outcomes (3)

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 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
Measured: 32 weeks (8 months)
Change in Subject Hair Self-Assessment Questionnaire scores
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
Measured: 32 weeks (8 months)
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: 32 weeks (8 months)

Timeline

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

16 Sep 2025May 2026

First posted31 May 2025
Study start16 Sep 2025
Primary completionMay 2026 (estimated)
Study completionMay 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Hair DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 15 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06999408
Sponsor's protocol ID: REC-2025-DERM-001-IIT
Status last verified: May 2025
First submitted: 14 May 2025
Last updated: 9 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: De-identified individual participant data (IPD) that underlie the results reported in this study will be shared.

Publications

Ha DH, Kim SD, Lee J, Kwon HH, Park GH, Yang SH, Jung JY, Lee JH, Park SR, Youn J, Lee SH, Kim JE, Lim J, Lee HK, Cho BS, Yi YW. Toxicological evaluation of exosomes derived from human adipose tissue-derived mesenchymal stem/stromal cells. Regul Toxicol Pharmacol. 2020 Aug;115:104686. doi: 10.1016/j.yrtph.2020.104686. Epub 2020 May 22.
PubMed 32450131
Ersan M, Ozer E, Akin O, Tasli PN, Sahin F. Effectiveness of Exosome Treatment in Androgenetic Alopecia: Outcomes of a Prospective Study. Aesthetic Plast Surg. 2024 Nov;48(21):4262-4271. doi: 10.1007/s00266-024-04332-3. Epub 2024 Aug 22.
PubMed 39174804
Zhou Y, Seo J, Tu S, Nanmo A, Kageyama T, Fukuda J. Exosomes for hair growth and regeneration. J Biosci Bioeng. 2024 Jan;137(1):1-8. doi: 10.1016/j.jbiosc.2023.11.001. Epub 2023 Nov 23.
PubMed 37996318
Kost Y, Muskat A, Mhaimeed N, Nazarian RS, Kobets K. Exosome therapy in hair regeneration: A literature review of the evidence, challenges, and future opportunities. J Cosmet Dermatol. 2022 Aug;21(8):3226-3231. doi: 10.1111/jocd.15008. Epub 2022 Jun 2.
PubMed 35441799
Gupta AK, Wang T, Rapaport JA. Systematic review of exosome treatment in hair restoration: Preliminary evidence, safety, and future directions. J Cosmet Dermatol. 2023 Sep;22(9):2424-2433. doi: 10.1111/jocd.15869. Epub 2023 Jun 28.
PubMed 37381168
Queen D, Avram MR. Exosomes for Treating Hair Loss: A Review of Clinical Studies. Dermatol Surg. 2025 Apr 1;51(4):409-415. doi: 10.1097/DSS.0000000000004480. Epub 2024 Oct 24.
PubMed 39447204

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hair Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06999408
Acronym / sponsor ID: REC-2025-DERM-001-IIT
Conditions: Hair Diseases, Alopecia, Hair Thinning
Keywords: Exosomes, TargetCool, Hair thinning, mirconeedling
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 15 participants (estimated)
Lead sponsor: Recens Medical, Inc.Industry (pharma, biotech, devices)
Collaborators: Benev Company, Inc.
Study start: 16 Sep 2025 (actual)
Primary completion: May 2026 (estimated)
Study completion: May 2026 (estimated)
First posted: 31 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
TargetCool with Benev exosome Boost	Active comparator	Device: Scalp tattoo, Device: Canfield HairMetrix®, Device: TargetCool
Microneedling followed by TargetCool Boosting with Benev exosome	Active comparator	Device: Scalp tattoo, Device: Canfield HairMetrix®, Device: TargetCool, Device: Microneedle-facilitated lidocaine application
Microneedling to depth of 0.5mm followed by Benev exosome topical	Active comparator	Device: Scalp tattoo, Device: Canfield HairMetrix®, Device: Microneedle-facilitated lidocaine application

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.
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 hair thinning as determined on initial study assessment by the Investigator.
Patients are not on medical treatment or have been on stable treatment for >12 months (eg. minoxidil, finasteride, dutasteride, PRP, LLLT)

Key exclusion criteria (8 listed)

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.
Subjects who have had a hair transplant.
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 who started any new hair loss treatment in the last 12 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 12 months, cyproterone acetate, aldactone/spironolactone or any 5-alpha-reductase inhibitor).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Scalp tattooA micropigmentation scalp tattoo will be applied at baseline to mark consistent photographic sites.	Device	Microneedling followed by TargetCool Boosting with Benev exosome, Microneedling to depth of 0.5mm followed by Benev exosome topical, TargetCool with Benev exosome Boost
Canfield HairMetrix®Canfield HairMetrix® imaging will be utilized to capture global and trichoscopic hair measurements.	Device	Microneedling followed by TargetCool Boosting with Benev exosome, Microneedling to depth of 0.5mm followed by Benev exosome topical, TargetCool with Benev exosome Boost
TargetCoolBoosting will be used to apply exosomes	Device	Microneedling followed by TargetCool Boosting with Benev exosome, TargetCool with Benev exosome Boost
Microneedle-facilitated lidocaine applicationMicroneedling will be performed to a depth of 0.5 mm.	Device	Microneedling followed by TargetCool Boosting with Benev exosome, Microneedling to depth of 0.5mm followed by Benev exosome topical

Primary outcome

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.
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.
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.
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.

3 secondary outcomes

Change in Investigator Hair Growth Global Improvement Scale
Time frame: 32 weeks (8 months)
Change in Subject Hair Self-Assessment Questionnaire scores
Time frame: 32 weeks (8 months)
Change in Hair Treatment Subject Satisfaction Questionnaire scores
Time frame: 32 weeks (8 months)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
Background: PubMed 32450131Ha DH, Kim SD, Lee J, Kwon HH, Park GH, Yang SH, Jung JY, Lee JH, Park SR, Youn J, Lee SH, Kim JE, Lim J, Lee HK, Cho BS, Yi YW. Toxicological evaluation of exosomes derived from human adipose tissue-derived mesenchymal stem/stromal cells. Regul Toxicol Pharmacol. 2020 Aug;115:104686. doi: 10.1016/j.yrtph.2020.104686. Epub 2020 May 22.
Background: PubMed 39174804Ersan M, Ozer E, Akin O, Tasli PN, Sahin F. Effectiveness of Exosome Treatment in Androgenetic Alopecia: Outcomes of a Prospective Study. Aesthetic Plast Surg. 2024 Nov;48(21):4262-4271. doi: 10.1007/s00266-024-04332-3. Epub 2024 Aug 22.
Background: PubMed 37996318Zhou Y, Seo J, Tu S, Nanmo A, Kageyama T, Fukuda J. Exosomes for hair growth and regeneration. J Biosci Bioeng. 2024 Jan;137(1):1-8. doi: 10.1016/j.jbiosc.2023.11.001. Epub 2023 Nov 23.
Background: PubMed 35441799Kost Y, Muskat A, Mhaimeed N, Nazarian RS, Kobets K. Exosome therapy in hair regeneration: A literature review of the evidence, challenges, and future opportunities. J Cosmet Dermatol. 2022 Aug;21(8):3226-3231. doi: 10.1111/jocd.15008. Epub 2022 Jun 2.
Background: PubMed 37381168Gupta AK, Wang T, Rapaport JA. Systematic review of exosome treatment in hair restoration: Preliminary evidence, safety, and future directions. J Cosmet Dermatol. 2023 Sep;22(9):2424-2433. doi: 10.1111/jocd.15869. Epub 2023 Jun 28.
Background: PubMed 39447204Queen D, Avram MR. Exosomes for Treating Hair Loss: A Review of Clinical Studies. Dermatol Surg. 2025 Apr 1;51(4):409-415. doi: 10.1097/DSS.0000000000004480. Epub 2024 Oct 24.
TargetCoolLink provided by the sponsor.
Exosome Regenerative Complex+Link provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in this study will be shared.

Related trials for Hair Diseases

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marc Avram, MD principal investigator

Dawn Queen, MD principal investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Scalp tattoo, Canfield HairMetrix® and TargetCool in people with Hair Diseases and Alopecia, run by Recens Medical, Inc. 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 10 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. 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?

This study is still under way. Results are not available in the source record yet.

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: 32 weeks (8 months)). The study lists 4 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 NCT06999408, which also lists 6 linked publications.

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 9 Mar 2026.