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

NCT06482541 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-07-16

No results posted yet for this study

Summary

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).

Conditions

Interventions

COMBINATION_PRODUCT

5 billion exosomes and saline solution microneedling

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.

COMBINATION_PRODUCT

50 billion exosomes and saline solution microneedling

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.

Sponsors & Collaborators

  • ResilielleTM Age ZeroTM Exosomes

    collaborator UNKNOWN

  • Dorisca Research Consulting, LLC

    collaborator UNKNOWN

  • Levit Dermatology

    lead OTHER

Principal Investigators

  • Eyal K Levit, M.D. · Owner and chief physician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-07-31
Completion
2025-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06482541 on ClinicalTrials.gov