Status:
NOT_YET_RECRUITING
Efficacy and Safety of TargetCool + Benev Exosomes in Patients With Hair Thinning
Lead Sponsor:
Recens Medical, Inc.
Collaborating Sponsors:
Benev Company, Inc.
Conditions:
Hair Diseases
Alopecia
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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, alo...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Subjects must be in general good health, as determined by the Investigator.
- Subjects with hair thinning as determined on initial study assessment by the Investigator.
- Patients are not on medical treatment or have been on stable treatment for \>12 months (eg. minoxidil, finasteride, dutasteride, PRP, LLLT)
- 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.
- 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.
- Subjects willing to have TargetCool boosting or microneedling of the scalp region with or followers by application of exosomes.
- Subjects must be willing and able to complete and understand the rating questionnaires.
- Subjects must be willing and able to attend all study visits and comply with the post procedure and lifestyle instructions
Exclusion
- 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.
- Subjects who have had a hair transplant.
- 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.
- Subjects who started any new hair loss treatment in the last 12 months.
- 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).
- 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.
- 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.
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06999408
Start Date
June 1 2025
End Date
May 1 2026
Last Update
May 31 2025
Active Locations (1)
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1
Marc Avram MD
New York, New York, United States, 10021