Not Yet RecruitingPhase 1

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

United States100 participantsStarted 2024-07

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hair count

Timeframe: Evaluated on monthly visits for a year

Hair thickness

Timeframe: Evaluated on monthly visits for a year

Hair color

Timeframe: Evaluated on monthly visits for a year

Trial details

NCT IDNCT06482541

SponsorLevit Dermatology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07

Contact for this trial

Eyal K Levit, M.D.

917-868-5112 eyallevit@gmail.com

View on ClinicalTrials.gov More Androgenetic Alopecia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.