1-Year Double-Blind Placebo-Controlled Study To EVALUATE THE EFFECT OF AGE ZERO™ EXOSOMES ON HAIR REGROWTH IN HEALTHY MEN AND WOMEN WITH ANDROGENETIC ALOPECIA
Levit Dermatology
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).
Description
After being informed about the study and potential risks, all participants who give written consent and meet the later discussed inclusion criteria and don't fall under the exclusion criteria will be enrolled in the study. The investigators will conduct a double-blind placebo-controlled study to test whether Wharton's Jelly Mesenchymal Stem Cell-derived Exosome (WJMSC-exosome) application with microneedling is an effective treatment for Androgenetic Alopecia. Participants will be broken down into a 5 billion exosome group vs. saline group and a 50 billion exosome vs. saline group. Treatment…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Participant is experiencing hair loss and is diagnosed with Androgenetic Alopecia. Exclusion Criteria: * Patients cannot have taken any medications, therapies, or treatment modalities of any kind to treat hair loss in the last six months. * Patients cannot have open wounds, eczema, or psoriatic plaques on the treatment area of the scalp. * Patients who are undergoing or have undergone chemotherapy and or radiation therapy within the past 6 months * Patients with a history of an autoimmune bullous disorder (having auto-antibodies to Dsg-1 or Dsg-3) * Patients who are cu…
Interventions
- Combination Product5 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 Product50 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.
Location
- Levit DermatologyBrooklyn, New York