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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Decellularized allogeneic human amniotic fluid
Biological/VaccineDecellularized 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
DrugSterile 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: XVIEExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 180Secondary outcomes
1
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)2
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)3
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)4
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)Other outcomes
1
Change in vellus-to-terminal hair ratio as measured by hair caliber distribution analysis using Canfield HairMetrix Automated Imaging System
Change from baseline in vellus-to-terminal hair ratio within the target area assessed by hair caliber distribution analysis.
Time frame
Baseline, Month 3 (Day 90), Month 6 (Day 180)2
Change in Total Area Hair Count (TAHC) durability as measured by Canfield HairMetrix Automated Imaging System between Treatment 2 and final visit
Comparison of efficacy outcomes between Month 3 (prior to Treatment 2) and Month 6 (3 months post-Treatment 2) to assess durability of response.
Time frame
Month 3 (Day 90) and Month 6 (Day 180)3
Proportion of participants achieving clinically meaningful increase in Total Area Hair Count (TAHC) as measured by Canfield HairMetrix Automated Imaging System
Proportion of subjects achieving 10% or greater and 15% or greater increase in TAHC from baseline at Month 3 and Month 6.
Time frame
Month 3 (Day 90), Month 6 (Day 180)Sponsors and contacts
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Source ClinicalTrials.gov
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