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

Levit Dermatology

Status and phase: Not yet enrolling; Phase 1

Conditions: Androgenetic Alopecia

Treatments: Combination Product: 50 billion exosomes and saline solution microneedling; Combination Product: 5 billion exosomes and saline solution microneedling

Study type: Interventional

Funder types: Other

Identifiers

NCT06482541

2023-06-001

Details and patient eligibility

About

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).

Full 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 will be applied to the following treatment area: two rectangles on the scalp vertex each measuring 4cm on the sagittal plane by 2cm on the coronal plane. 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. Each treatment area will be divided into an anterior and posterior half with 1 permanent microdot tattoo in the middle (4 tattoos in total). The microdot tattoo (composed of Iron Oxide, Glycerol, Alcohol, and distilled Water and Red - D&C Red #30, Glycerol, Alcohol and distilled water) will allow HairMatrix® by Canfield, an AI-driven hair consultation device, to accurately and reproducibly access changes in hair growth in the treatment areas.

Participants in the 5 billion exosome group will receive topical applications of 5 billion WJMSC-exosomes on one side of the treatment area and an equal volume of placebo (an identically-looking saline solution) application on the opposite side of the treatment area.

The 50 billion exosome group will receive topical applications of 50 billion WJMSC-exosomes on one side of the treatment area and an equal volume of placebo application on the opposite side of the treatment area.

Immediately after topical application, all participants will receive microneedling at a depth of .5 mm on the entire treatment area.

Treatment will be administered in 4 sessions, monthly for the first three months and for a 4th time 4 months after the third session.

The study will go on for 12 months from the date of the first treatment. Participant's changes in hair growth (hair count, hair thickness, and hair color) and adverse events will be evaluated and recorded.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

5 billion exosome group

Experimental group

Description:

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.

Treatment:

Combination Product: 5 billion exosomes and saline solution microneedling

50 billion exosome group

Experimental group

Description:

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.

Treatment:

Combination Product: 50 billion exosomes and saline solution microneedling