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

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™. 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.

Conditions

• Hair Diseases
• Alopecia
• Hair Thinning

Interventions

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.

Sponsors & Collaborators

• Benev Company, Inc.

  collaborator INDUSTRY

• Recens Medical, Inc.

  lead INDUSTRY

Principal Investigators

• Marc Avram, MD

• Dawn Queen, MD

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-16

Primary Completion

2026-05-31

Completion

2026-05-31

FDA Device

Yes

Countries

• United States

Study Locations