XVIE to Treat Androgenetic Alopecia (AGA)

Part of paid clinical trials in Orlando, Florida.

Sponsor
Restore Biologics Holdings, Inc. dba Xtressé
Study ID
NCT07482423
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Decellularized allogeneic human amniotic fluid — BIOLOGICAL
    Decellularized allogeneic human amniotic fluid (hAF) processed by centrifugation and sterile filtration to remove cellular components while preserving bioactive growth factors, extracellular vesicles, and hyaluronic acid. Supplied as a ready-to-use 2.0 mL frozen liquid in a borosilicate glass vial. Administered undiluted via intradermal scalp injection across 20 sites (0.1 mL per site, 4-5 mm depth, 30-gauge needle). Manufactured by Nova Vita Laboratories, LLC.
  • Sodium chloride 0.9% injectable solution — DRUG
    Sterile 0.9% sodium chloride for injection supplied in 2.0 mL borosilicate glass vials identical in appearance, packaging, and labeling to the active product. Administered via intradermal scalp injection across 20 sites (0.1 mL per site, 4-5 mm depth, 30-gauge needle) at Day 0 and Day 90.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: XVIE
    Participants receive 2.0 mL of XVIE (decellularized allogeneic human amniotic fluid) administered via intradermal scalp injection at Day 0 and Day 90. Product is delivered across 20 injection sites (0.1 mL per site) at 4-5 mm depth using a 30-gauge needle.
  • Placebo Comparator: Placebo
    Participants receive 2.0 mL of sterile 0.9% sodium chloride for injection (normal saline) administered via intradermal scalp injection at Day 0 and Day 90. Delivered across 20 injection sites (0.1 mL per site) at 4-5 mm depth using a 30-gauge needle. Placebo is supplied in identical vials with identical packaging and labeling to the active product.

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (TE-AEs) and treatment-emergent serious adverse events (TE-SAEs) as assessed by CTCAE v5.0 [ Time Frame: Baseline through Day 180 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Advanced Dermatology and Cosmetic SurgeryOrlandoFlorida32827
Matt Leavitt, DO
[email protected]
(407) 745-1966
Kindred Hair & Skin CenterMarriottsvilleMaryland21104
Chesahna Kindred, MD
[email protected]
(443) 424-7754

Find similar trials in Orlando, FL

By research site
Advanced Dermatology and Cosmetic Surgery· Orlando, FLKindred Hair & Skin Center· Marriottsville, MD

Related Studies