XVIE to Treat Androgenetic Alopecia (AGA)

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.

NCT Number	NCT07482423
Lead Sponsor	Restore Biologics Holdings, Inc. dba Xtressé
Conditions	Androgenetic Alopecia
Enrollment	30 participants
Start Date	2026-12-01
Primary Completion	2028-05-01 (estimated)
Study Completion	2028-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-12