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.
This Phase I/II randomized, double-blind, placebo-controlled trial evaluates the safety and preliminary efficacy of XVIE (decellularized allogeneic human amniotic fluid) administered via intradermal scalp injection in adults with androgenetic alopecia (AGA). XVIE is manufactured by Nova Vita Laboratories, LLC under cGMP-aligned conditions. It contains naturally occurring soluble proteins, extracellular vesicles (nanoparticles 50-200 nm), and hyaluronic acid derived from full-term human amniotic fluid. Cellular components are removed by centrifugation and sterile filtration. Each lot is released against a 7-parameter specification panel including nanoparticle concentration, size, total protein, sterility, endotoxin, mycoplasma, and appearance. Thirty adults (ages 18-70) with AGA will be randomized 1:1 to XVIE or placebo (0.9% saline). Both are supplied in identical 2.0 mL vials. Treatment is administered intradermally across 20 scalp injection sites (0.1 mL per site, 4-5 mm depth, 30-gauge needle) at Day 0 and Day 90. Final assessment occurs at Day 180 with no treatment administered. Safety assessments include incidence, severity, and relatedness of treatment-emergent adverse events (TE-AEs) and serious adverse events (TE-SAEs), graded per CTCAE v5.0. Adverse events of special interest include scalp-specific events such as new-onset alopecia in previously unaffected areas, a decrease of 15% or greater in Total Area Hair Count within the injection zone, and scarring alopecia not consistent with natural AGA progression. Efficacy assessments include Total Area Hair Count and hair density measured by Canfield HairMetrix imaging, global scalp coverage by SoCAI Global HairMap, Investigator and Subject Global Assessments (7-point scale), and quality of life via the Dermatology Life Quality Index (DLQI). Male subjects must be Norwood-Hamilton Stage III-IVa; female subjects must be Ludwig Stage I-II. The study is conducted at two U.S. clinical sites: Advanced Dermatology and Cosmetic Surgery in Orlando, FL and Kindred Hair \& Skin Center in Marriottsville, MD. An independent Data Safety Monitoring Board (DSMB) will oversee participant safety throughout the trial. Enrollment will not begin until the DSMB is fully constituted and the DSMB Charter has been executed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
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.
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.
Advanced Dermatology and Cosmetic Surgery
Orlando, Florida, United States
Kindred Hair & Skin Center
Marriottsville, Maryland, United States
Number of participants with treatment-emergent adverse events (TE-AEs) and treatment-emergent serious adverse events (TE-SAEs) as assessed by CTCAE v5.0
Incidence, severity, and relatedness of all TE-AEs and TE-SAEs graded per CTCAE v5.0, including protocol-defined adverse events of special interest: new-onset alopecia in previously unaffected scalp areas, decrease of 15% or greater in Total Area Hair Count (TAHC) within the injection zone relative to baseline, and Investigator-determined scarring alopecia not consistent with natural AGA progression.
Time frame: Baseline through Day 180
Change in Total Area Hair Count (TAHC) as measured by Canfield HairMetrix Automated Imaging System
Change from baseline in total hair count within a defined target area (approximately 1.9 cm²) measured by Canfield HairMetrix automated imaging. Target area marked with scalp tattoo dots for precise repositioning at each visit.
Time frame: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Change in hair density (hairs/cm²) as measured by Canfield HairMetrix Automated Imaging System
Change from baseline in hair density (hairs/cm²) within the defined target area measured by Canfield HairMetrix imaging.
Time frame: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Change in mean hair shaft diameter (mm) as measured by Canfield HairMetrix Automated Imaging System
Change from baseline in mean hair shaft diameter/caliber (mm) within the defined target area measured by Canfield HairMetrix imaging.
Time frame: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Change in global scalp coverage percentage as measured by SoCAI Global HairMap Imaging Platform
Change from baseline in scalp coverage percentage and continuous density score assessed by SoCAI Global HairMap AI-driven imaging platform with heat map visualization.
Time frame: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Proportion of participants with improved hair growth response as assessed by Investigator Global Assessment (IGA) 7-point scale
Investigator-rated hair growth response compared to baseline using the Investigator Global Assessment 7-point scale. Scores range from -3 (greatly decreased) to +3 (greatly increased), where higher scores indicate greater hair growth improvement. A score of 0 indicates no change. Responder rate defined as proportion of participants achieving a score of +1 or greater.
Time frame: Month 3 (Day 90), Month 6 (Day 180)
Proportion of participants with improved hair growth response as assessed by Subject Global Assessment (SGA) 7-point scale
Subject-rated perceived hair growth response compared to baseline using the Subject Global Assessment 7-point scale. Scores range from -3 (greatly decreased) to +3 (greatly increased), where higher scores indicate greater perceived hair growth improvement. A score of 0 indicates no change. Responder rate defined as proportion of participants achieving a score of +1 or greater.
Time frame: Month 3 (Day 90), Month 6 (Day 180)
Change in subject-reported quality of life from baseline as assessed by Dermatology Life Quality Index (DLQI) questionnaire
Change from baseline in subject-reported quality of life assessed by the validated 10-item Dermatology Life Quality Index questionnaire measuring the impact of skin conditions on daily functioning. Scores range from 0 to 30, where higher scores indicate greater impairment in quality of life. A score of 0 indicates no impairment.
Time frame: Baseline, Month 3 (Day 90), Month 6 (Day 180)
Melissa Rayner
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.