XVIE to Treat Androgenetic Alopecia (AGA)

Official title

A Phase I/II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Potential Efficacy of XVIE Injected Intradermally in Patients With Androgenetic Alopecia

Overview

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.

Detailed description

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.

Interventions

• Biological Decellularized allogeneic human amniotic fluid
  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.
• Drug Sodium chloride 0.9% injectable solution
  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.

Primary outcome measures

• 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]

Secondary outcome measures (7)

• Change in Total Area Hair Count (TAHC) as measured by Canfield HairMetrix Automated Imaging System [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 [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 [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 [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 [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 [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 [Time frame: Baseline, Month 3 (Day 90), Month 6 (Day 180)]

Eligibility criteria

Inclusion criteria

• 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
• Clinical diagnosis of androgenetic alopecia (AGA) with documented hair loss for at least 6 months prior to screening
• Stable pattern of hair loss (no rapid progression) for at least 6 months prior to screening
• Male subjects: Norwood-Hamilton Classification Stage III, IIIa, IIIv, IV, or IVa
• Female subjects: Ludwig Classification Stage I or II
• Normal thyroid function (TSH within normal limits) at screening, or stable on thyroid replacement therapy for at least 6 months
• Ferritin level within normal limits at screening, or documented adequate iron stores
• No clinically significant abnormalities on CBC with differential or comprehensive metabolic panel (CMP) at screening outside protocol-defined eligibility thresholds
• Female subjects of childbearing potential must have a negative urine pregnancy test at screening and agree to use an effective method of contraception throughout the study and for 30 days after the last treatment
• Female subjects who are postmenopausal (no menses for at least 12 months) or surgically sterile are not required to use contraception

Exclusion criteria

• 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
• Hair transplant surgery within 12 months prior to screening
• Low-level laser therapy (LLLT) or other light-based hair treatments within 3 months prior to screening
• Scalp microneedling within 3 months prior to screening
• Use of drugs with anti-androgenic properties (e.g., spironolactone, cyproterone acetate, flutamide) within 6 months prior to screening
• Systemic corticosteroids within 2 weeks prior to screening, or corticosteroid scalp injections within 1 month prior to screening
• Chronic daily NSAID use (defined as daily use for 14 or more consecutive days), other than low-dose aspirin (81 mg/day or less) for cardiovascular prophylaxis
• Diagnosis or history of alopecia areata, cicatricial (scarring) alopecia, telogen effluvium, traction alopecia, or other non-AGA hair loss conditions
• Norwood-Hamilton Stage V, VI, or VII (male subjects); Ludwig Stage III (female subjects)
• Active or history of malignancy within 5 years prior to screening, except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
• Known or suspected autoimmune disease (e.g., lupus, rheumatoid arthritis, psoriasis with scalp involvement)
• Known or newly identified immunodeficiency or immunocompromised state, including HIV infection identified at screening
• Positive for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) at screening
• Platelet count less than 100,000/µL, bleeding disorder, or hemoglobin less than 10 g/dL at screening
• Current use of anticoagulant therapy (e.g., warfarin, heparin, direct oral anticoagulants), P2Y12 receptor inhibitors (e.g., clopidogrel, prasugrel, ticagrelor), phosphodiesterase inhibitor antiplatelet agents (e.g., cilostazol, dipyridamole), or dual antiplatelet therapy
• Uncontrolled thyroid disease or thyroid dysfunction not adequately managed on stable therapy
• Uncontrolled diabetes (HbA1c greater than 9%) or other significant metabolic disorder
• Active scalp infection, inflammation, or dermatological condition in the treatment area
• Open wounds, abrasions, or abnormalities on the scalp in the intended treatment area
• History of keloid formation or propensity for keloids
• Hair weaving or use of hair pieces that cannot be removed for study assessments
• Known hypersensitivity or allergy to any component of XVIE or human-derived biological products
• Known allergy to lidocaine or other local anesthetics
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
• Positive urine pregnancy test at screening or Day 0
• Participation in another interventional clinical trial within 30 days prior to screening or concurrent participation in another clinical study
• History of drug or alcohol abuse within 12 months prior to screening
• Use of systemic immunosuppressive therapy within 5 half-lives or 30 days prior to screening, whichever is longer, including biologic agents, conventional DMARDs, JAK inhibitors, and calcineurin inhibitors
• Use of topical JAK inhibitors applied to the scalp within 30 days prior to screening
• Any condition that, in the Investigator's judgment, would make the subject unsuitable for study participation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• Advanced Dermatology and Cosmetic Surgery — Orlando
• Kindred Hair & Skin Center — Marriottsville

Publications

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• Honda M, Ichibayashi R, Yokomuro H, Yoshihara K, Masuda H, Haga D, Seiki Y, Kudoh C, Kishi T. Early Cerebral Circulation Disturbance in Patients Suffering from Severe Traumatic Brain Injury (TBI): A Xenon CT and Perfusion CT Study. Neurol Med Chir (Tokyo). 2016 Aug 15;56(8):501-9. doi: 10.2176/nmc.oa.2015-0341. Epub 2016 Jun 29. PMID 27356957
• Zhang Q, Wang H, Shi Y, Li W. White matter biomarker for predicting de novo Parkinson's disease using tract-based spatial statistics: a machine learning-based model. Quant Imaging Med Surg. 2024 Apr 3;14(4):3086-3106. doi: 10.21037/qims-23-1478. Epub 2024 Mar 28. PMID 38617147
• Cappelli G, Giovannini D, Vilardo L, Basso A, Iannetti I, Massa M, Ruberto G, Muir R, Pastore C, D'Agnano I, Mariani F. Cinnamomum zeylanicum Blume Essential Oil Inhibits Metastatic Melanoma Cell Proliferation by Triggering an Incomplete Tumour Cell Stress Response. Int J Mol Sci. 2023 Mar 16;24(6):5698. doi: 10.3390/ijms24065698. PMID 36982774
• Mu J, Zhang Z, Wu L, Fu J, Chen B, Yan Z, Li B, Zhou Z, Wang W, Zhao L, Dong J, Kuang Y, Sun X, He L, Wang L, Sang Q. The identification of novel mutations in PLCZ1 responsible for human fertilization failure and a therapeutic intervention by artificial oocyte activation. Mol Hum Reprod. 2020 Feb 29;26(2):80-87. doi: 10.1093/molehr/gaaa003. PMID 31953539
• Ahmad Nizaruddin M, Omar MS, Mhd-Ali A, Makmor-Bakry M. A qualitative study exploring issues related to medication management in residential aged care facilities. Patient Prefer Adherence. 2017 Nov 1;11:1869-1877. doi: 10.2147/PPA.S144513. eCollection 2017. PMID 29138540
• Harmatz PR, Lampe C, Parini R, Sharma R, Teles EL, Johnson J, Sivam D, Sisic Z. Enzyme replacement therapy outcomes across the disease spectrum: Findings from the mucopolysaccharidosis VI Clinical Surveillance Program. J Inherit Metab Dis. 2019 May;42(3):519-526. doi: 10.1002/jimd.12079. Epub 2019 Apr 8. PMID 30834539

Identifiers

NCT: NCT07482423 · RBH-2026-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗