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XVIE to Treat Androgenetic Alopecia (AGA)

StatusNot Yet Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later May 1, 2027 → May 1, 2028
See other at-risk trials from Restore Biologics Holdings, Inc. dba Xtressé

Record History

  1. Primary and study completion pushed from May 1, 2027 to May 1, 2028
    • Start date: May 1, 2026 to Dec 1, 2026
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07482423
Lead Sponsor Restore Biologics Holdings, Inc. dba Xtressé
Conditions
(from sponsor)		 Androgenetic Alopecia
Related terms Alopecia
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov