Androgenetic Alopecia
Conditions
Keywords
exosomes, Androgenetic Alopecia
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.
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.
Sponsors
ResilielleTM Age ZeroTM Exosomes
Dorisca Research Consulting, LLC
Levit Dermatology
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 currently immunocompromised or have a low white count making patients prone to infections.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hair count | Evaluated on monthly visits for a year | Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device |
| Hair thickness | Evaluated on monthly visits for a year | Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device |
| Hair color | Evaluated on monthly visits for a year | Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Participants will self-report adverse events during monthly visits for the entire 1-year duration | Patients will self-report adverse events on a questionnaire on a scale of 1-10, with 1 being minimal discomfort and 10 being worst discomfort ever experienced. |
| Self-reported hair changes | Patients will self-report on questionnaire during monthly visits for the entire 1-year duration | Patients will self-report impressions of hair growth changes on each treatment area on a scale of -10 to 10, with -10 being extreme worsening of hair loss and 10 being extreme regrowth. Patients will scale impressions of hair thickness, hair density, hair color, hair growth speed, hair texture, and overall satisfaction with therapy applied to each treatment area. |
Countries
United States
Contacts
Primary ContactEyal K Levit, M.D.
Backup ContactNicholas L Gitsin
Outcome results
None listed