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Efficacy and Safety of TargetCool + Benev Exosomes in Patients With Hair Thinning
NCT06999408 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE Scalp tattoo
- DEVICE Canfield HairMetrix®
- DEVICE TargetCool
- DEVICE Microneedle-facilitated lidocaine application
Study Locations (1)
New York
- Marc Avram MD — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-09-16 |
| Est. Completion | 2026-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06999408
The ClinicalTrials.gov registry entry for NCT06999408 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Recens Medical, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Alopecia appearing as the primary indexed condition, and to 4 interventions — of which Scalp tattoo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06999408 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06999408 about?
NCT06999408 is a clinical study titled "Efficacy and Safety of TargetCool + Benev Exosomes in Patients With Hair Thinning". 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 determin...
What is the current status of trial NCT06999408?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2025-09-16. Estimated completion is 2026-05.
What conditions does trial NCT06999408 study?
This clinical trial studies the following conditions: Alopecia, Hair Thinning, Hair Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06999408?
The interventions under investigation include: Scalp tattoo (DEVICE), Canfield HairMetrix® (DEVICE), TargetCool (DEVICE), Microneedle-facilitated lidocaine application (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06999408?
This trial is sponsored by Recens Medical, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06999408 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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