Clinical trial NCT06482541: Efficacy and Safety Of AGE ZERO™ EXOSOMES To Treat Men and Women With Androgenetic Alopecia
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Androgenetic Alopecia
Keywords: exosomes
Androgenetic Alopecia
Lead sponsor: Levit Dermatology
Sponsor class: OTHER
Collaborators: name: ResilielleTM Age ZeroTM Exosomes
name: Dorisca Research Consulting, LLC
First posted: 2024-07-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hair count
timeFrame: Evaluated on monthly visits for a year
measure: Hair thickness
timeFrame: Evaluated on monthly visits for a year
measure: Hair color
timeFrame: Evaluated on monthly visits for a year
Secondary outcomes:
measure: Adverse events
timeFrame: Participants will self-report adverse events during monthly visits for the entire 1-year duration
measure: Self-reported hair changes
timeFrame: Patients will self-report on questionnaire during monthly visits for the entire 1-year duration
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Levit Dermatology
state: New York
Study officials:
affiliation: Owner and chief physician
name: Eyal K Levit, M.D.
role: PRINCIPAL_INVESTIGATOR
References: