TargetCool + Benev Exosomes for Alopecia

Overseen By Jen Clinical Program Director

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Recens Medical, Inc.

Must not be taking: Anti-androgens, Hormones, 5-alpha-reductase

Disqualifiers: Pregnancy, Hair transplant, Uncontrolled diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 9 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Marc Avram, MD

Principal Investigator

Dawn Queen, MD

Principal Investigator

Eligibility Criteria

This trial is for healthy men aged 18-70 and women around 45-70 who are not of childbearing potential, experiencing hair thinning. Participants must be willing to undergo cosmetic treatments including microneedling and application of exosomes with or without a cooling device.

Inclusion Criteria

I am willing to undergo scalp treatments with TargetCool or microneedling followed by exosome application.

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

I am a healthy male aged 18-70 or a female aged 45-70 not able to have children.

Exclusion Criteria

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

I have had a hair transplant.

I have been on a stable dose of birth control or hormone replacement therapy for 3+ months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive four treatments over 9 weeks, which may include microneedling, TargetCool™ treatment, and exosome application depending on group assignment

9 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 3 and 6 months after the final treatment

32 weeks

2 visits (in-person)

Treatment Details

Interventions

• Exosomes
• Microneedling
• TargetCool

Trial Overview The study tests the effectiveness of combining exosomes (particles from stem cells) with a precision cooling device (TargetCool™) and microneedling on scalp health. It's divided into three groups: one receiving just exosomes, another adding TargetCool™, and the third using both plus microneedling.

Participant Groups

Group I: Microneedling followed by TargetCool Boosting with Benev exosome Active Control 4 Interventions

Group II: Microneedling to depth of 0.5mm followed by Benev exosome topical Active Control 3 Interventions

Group III: TargetCool with Benev exosome Boost Active Control 3 Interventions

Who Is Running the Clinical Trial?

Recens Medical, Inc.

Lead Sponsor

Trials

2

Recruited

120+

Benev Company, Inc.

Industry Sponsor

Trials

3

Recruited

130+