NCT06999408

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Recens Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-09-16
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-05-31
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study