Can stem cell particles and cooling restore thinning hair?
NCT ID NCT06999408
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether applying exosomes (tiny particles from stem cells) to the scalp, along with microneedling and a cooling device, can improve hair density in adults with non-scarring hair thinning. About 15 healthy men and women will be randomly assigned to one of three treatment groups and receive four sessions over 9 weeks. Researchers will measure hair changes using special imaging over 8 months to see if this combination is safe and effective.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Marc Avram MD
New York, New York, 10021, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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