Health TrialsbyHealthPanel

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

ConditionAndrogenetic Alopecia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLevit Dermatology

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participant is experiencing hair loss and is diagnosed with Androgenetic Alopecia.

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 5 billion exosomes and saline solution microneedling

    Combination 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 microneedling

    Combination 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: 5 billion exosome groupExperimental treatment 1 intervention
Group B: 50 billion exosome groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hair count

Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device

Time frame
Evaluated on monthly visits for a year
2

Hair thickness

Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device

Time frame
Evaluated on monthly visits for a year
3

Hair color

Evaluated by HairMatrix® by Canfield, an AI-driven hair consultation device

Time frame
Evaluated on monthly visits for a year

Secondary outcomes

1

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.

Time frame
Participants will self-report adverse events during monthly visits for the entire 1-year duration
2

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.

Time frame
Patients will self-report on questionnaire during monthly visits for the entire 1-year duration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Levit Dermatology

Lead sponsor

ResilielleTM Age ZeroTM Exosomes

Collaborator

Dorisca Research Consulting, LLC

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: