Androgenetic AlopeciaPhase 1NCT06482541
Efficacy and Safety Of AGE ZERO™ EXOSOMES To Treat Men and Women With Androgenetic Alopecia
A Phase 1 study testing 5 billion exosomes and saline solution microneedling and 50 billion exosomes and saline solution microneedling in people with Androgenetic Alopecia, run by Levit Dermatology at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- 5 billion exosomes and saline solution microneedling and 50 billion exosomes and saline solution microneedling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2024to Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is experiencing hair loss and is diagnosed with Androgenetic Alopecia.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Levit Dermatology
Brooklyn, New York, 11235
Eyal K Levit, MD, 917-868-5112, eyallevit@gmail.com
Nicholas L Gitsin, 347-932-9894, nicholasgitsin8a@gmail.com
About this study
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
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).
Read the 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.
- Conditions
- Androgenetic Alopecia
- Being tested
- 5 billion exosomes and saline solution microneedling, 50 billion exosomes and saline solution microneedling
- Keywords
- exosomes, Androgenetic Alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 billion exosomes and saline solution microneedlingCombination 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.
50 billion exosomes and saline solution microneedlingCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: 50 billion exosomes and saline solution microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair count
Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device
Measured: Evaluated on monthly visits for a year
Hair thickness
Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device
Measured: Evaluated on monthly visits for a year
Hair color
Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device
Measured: Evaluated on monthly visits for a year
Secondary outcomes (2)
Adverse events
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.
Measured: Participants will self-report adverse events during monthly visits for the entire 1-year duration
Self-reported hair changes
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.
Measured: Patients will self-report on questionnaire during monthly visits for the entire 1-year duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Levit Dermatology
- Sponsor type
- University, hospital or other
- Collaborators
- ResilielleTM Age ZeroTM Exosomes, Dorisca Research Consulting, LLC
- Responsible party
- Sponsor
- Investigators
- Eyal K Levit, M.D., Principal investigator, Owner and chief physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482541
- Sponsor's protocol ID
- 2023-06-001
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06482541
- Acronym / sponsor ID
- 2023-06-001
- Conditions
- Androgenetic Alopecia
- Keywords
- exosomes, Androgenetic Alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Levit DermatologyUniversity, hospital or other
- Collaborators
- ResilielleTM Age ZeroTM Exosomes, Dorisca Research Consulting, LLC
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 5 billion exosome group | Experimental | Combination Product: 5 billion exosomes and saline solution microneedlingThis 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. |
| 50 billion exosome group | Experimental | Combination Product: 50 billion exosomes and saline solution microneedlingThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participant is experiencing hair loss and is diagnosed with Androgenetic Alopecia.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 billion exosomes and saline solution microneedlingParticipants 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 product | 5 billion exosome group |
| 50 billion exosomes and saline solution microneedlingParticipants 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. | Combination product | 50 billion exosome group |
Primary outcome
Hair count
Time frame: Evaluated on monthly visits for a year
Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device
Hair thickness
Time frame: Evaluated on monthly visits for a year
Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device
Hair color
Time frame: Evaluated on monthly visits for a year
Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device
2 secondary outcomes
Adverse events
Time frame: Participants will self-report adverse events during monthly visits for the entire 1-year duration
Self-reported hair changes
Time frame: Patients will self-report on questionnaire during monthly visits for the entire 1-year duration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyal K Levit, M.D. principal investigator
Owner and chief physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5 billion exosomes and saline solution microneedling and 50 billion exosomes and saline solution microneedling in people with Androgenetic Alopecia, run by Levit Dermatology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eyal K Levit, M.D. (917-868-5112, eyallevit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair count (time frame: Evaluated on monthly visits for a year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.