XVIE to Treat Androgenetic Alopecia (AGA)
ConditionAndrogenetic Alopecia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRestore Biologics Holdings, Inc. dba Xtressé
About this trial
This study tests whether XVIE, an investigational injectable product made from processed human amniotic fluid, is safe and may help regrow hair in adults with androgenetic alopecia (common pattern hair loss). XVIE contains growth factors and extracellular vesicles that may stimulate hair follicle activity. Thirty participants will be randomly assigned to receive either XVIE or a saline placebo injected into the scalp in two treatment sessions, 90 days apart. Neither participants nor study staff will know which treatment is being given. Participants will be followed for 6 months. The main goal is to evaluate safety. A secondary goal is to assess whether hair count, density, or coverage improves.
Eligibility criteria
Qualifiers
Male or female, aged 18 to 70 years (inclusive) at the time of informed consent
Able to understand and voluntarily provide written informed consent
Willing and able to comply with study procedures, including all scheduled visits and assessments
In good general health as determined by the Investigator based on medical history and screening assessments
Disqualifiers
Use of topical or oral minoxidil within 3 months prior to screening
Use of oral finasteride or dutasteride within 6 months prior to screening
Use of topical finasteride within 3 months prior to screening
Platelet-rich plasma (PRP), exosome, or other regenerative scalp injections within 6 months prior to screening
Trial design
Treatments tested in this trial
- Decellularized allogeneic human amniotic fluid
- Sodium chloride 0.9% injectable solution
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov