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

Launched by RECENS MEDICAL, INC. · May 22, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help people with hair thinning by using a combination of treatments. The study focuses on applying exosomes, which are tiny particles that come from stem cells and may help regenerate hair, along with a device called TargetCool™ that cools the scalp to reduce discomfort. Participants will also undergo microneedling, a procedure that uses small needles to stimulate the scalp. The goal is to see if this combination of treatments can improve hair growth and health.

To join the study, participants need to be healthy men aged 18 to 70 or women aged 45 to 70 who are not able to become pregnant. They should have hair thinning and not be on any hair loss treatments for at least a year. If eligible, participants will receive four treatment sessions over nine weeks, which may include microneedling, cooling, and exosome application, depending on their assigned group. They will have follow-up visits three and six months after finishing the treatments to track their hair growth. This study is not yet recruiting, but it aims to provide important information on the safety and effectiveness of these combined treatments for hair thinning.

Gender

ALL

Eligibility criteria

• 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.