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

NCT06482541 | Not Yet Recruiting Phase 1

• 1 other identifier: 2023-06-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Androgenetic Alopecia

Keywords

exosomes; Androgenetic Alopecia

Outcome Measures

Primary Outcomes (3)

• Hair count

  Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device

  Evaluated on monthly visits for a year

• Hair thickness

  Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device

  Evaluated on monthly visits for a year

• Hair color

  Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device

  Evaluated on monthly visits for a year

Secondary Outcomes (2)

• Adverse events

  Participants will self-report adverse events during monthly visits for the entire 1-year duration

• Self-reported hair changes

  Patients will self-report on questionnaire during monthly visits for the entire 1-year duration

Study Arms (2)

5 billion exosome group

EXPERIMENTAL

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.

Combination Product: 5 billion exosomes and saline solution microneedling

50 billion exosome group

EXPERIMENTAL

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.

Combination Product: 50 billion exosomes and saline solution microneedling

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.

5 billion exosome group

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.

50 billion exosome group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is experiencing hair loss and is diagnosed with Androgenetic Alopecia.

You may not qualify if:

• 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 currently immunocompromised or have a low white count making patients prone to infections.

Sponsors & Collaborators

• Levit Dermatology: lead
• ResilielleTM Age ZeroTM Exosomes: collaborator
• Dorisca Research Consulting, LLC: collaborator

Study Sites (1)

Levit Dermatology

Brooklyn, New York, 11235, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Eyal K Levit, M.D.

  Owner and chief physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyal K Levit, M.D.

CONTACT

917-868-5112; eyallevit@gmail.com

Nicholas L Gitsin

CONTACT

347-932-9894; nicholasgitsin8a@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will act as their own control. Each participant will get exosome treatment on one half of the treatment area and placebo on the other half of the treatment area. The treatment area will be two rectangles each measuring 4cm on the sagittal plane by 2cm on the coronal plane on the scalp vertex. One rectangle will be 2.0 mm left of the midline of the scalp and another will be 2.0 mm right of the midline of the scalp. Participants in the 5 billion exosome group will receive 5 billion WJMSC-exosome treatment on one side of the treatment area and an equivalent volume of saline on the other side of the treatment area. Participants in the 50 billion exosome group will receive 5 billion WJMSC-exosome treatment on one side of the treatment area and an equivalent volume of placebo on the other side of the treatment area.

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 1, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

US (1)