Efficacy and Safety Of AGE ZERO™ EXOSOMES To Treat Men and Women With Androgenetic Alopecia

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Levit Dermatology
Study ID
NCT06482541
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 5 billion exosomes and saline solution microneedling — COMBINATION_PRODUCT
    Participants will receive 5 billion WJMSC-exosome topical application on one half of the treatment area and an equivalent volume of saline solution on the contralateral half of the treatment area. Microneedling at a depth of .5mm on the entire treatment area will immediately follow the exosome and saline application. Participants will also receive 4 permanent microdot tattoos on the aforementioned locations.
  • 50 billion exosomes and saline solution microneedling — COMBINATION_PRODUCT
    Participants will receive 50 billion WJMSC-exosome topical application on one half of the treatment area and an equivalent volume of saline solution on the contralateral half of the treatment area. Microneedling at a depth of .5mm on the entire treatment area will immediately follow the exosome and saline application. Participants will also receive 4 permanent microdot tattoos on the aforementioned locations.

Study Details

The purpose of this study is to determine whether Wharton's Jelly mesenchymal stem cell-derived exosome microneedling on the scalp is an effective treatment for Androgenetic Alopecia (pattern hair loss).

Key Dates

Start date
Jul 31, 2024
Status verified
Jul 2024
Primary completion
Jul 31, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 5 billion exosome group
    This arm receives 5 billion WJMSC-exosome treatment on one side of the aforementioned treatment area and an equivalent volume of placebo on the contralateral half of the treatment area.
  • Experimental: 50 billion exosome group
    This arm receives 50 billion WJMSC-exosome treatment on one half of the aforementioned treatment area and an equivalent volume of placebo on the contralateral half of the treatment area.

Primary Outcome Measure

Hair count [ Time Frame: Evaluated on monthly visits for a year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Levit DermatologyBrooklynNew York11235
Eyal K Levit, MD
[email protected]
917-868-5112
Nicholas L Gitsin
[email protected]
347-932-9894
Eyal K Levit, M.D. (PRINCIPAL_INVESTIGATOR)
Carla Mazzeo, M.Sc, Ph.D (SUB_INVESTIGATOR)
Nicholas L Gitsin (SUB_INVESTIGATOR)

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By research site
Levit Dermatology· Brooklyn, NY

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