XVIE to Treat Androgenetic Alopecia (AGA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Biological: Decellularized allogeneic human amniotic fluid; Drug: Sodium chloride 0.9% injectable solution

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Trillitye Paullin, PhD; Phone Number: 855-284-8266; Email: trill@xtresse.com
• Study Contact Backup: Name: Melissa Rayner

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32827
      • Advanced Dermatology and Cosmetic Surgery
      • Contact: Matt Leavitt, DO; Phone Number: (407) 745-1966; Email: info@xtresse.com
  • Maryland
    • Marriottsville, Maryland, United States, 21104
      • Kindred Hair & Skin Center
      • Contact: Chesahna Kindred, MD; Phone Number: (443) 424-7754; Email: info@kindredhairandskin.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline through Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Baseline, Month 3 (Day 90), Month 6 (Day 180)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Month 3 (Day 90), Month 6 (Day 180)
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.	Month 3 (Day 90) and Month 6 (Day 180)
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.	Month 3 (Day 90), Month 6 (Day 180)

Collaborators and Investigators

• Sponsor: Restore Biologics Holdings, Inc. dba Xtressé

Publications and helpful links

General Publications

• Radjenovic PM, Hardwick LJ. Time-resolved SERS study of the oxygen reduction reaction in ionic liquid electrolytes for non-aqueous lithium-oxygen cells. Faraday Discuss. 2018 Jan 1;206:379-392. doi: 10.1039/c7fd00170c. Epub 2017 Sep 29.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Androgenetic alopecia; Extracellular vesicles; Intradermal injection; Pattern hair loss; Human amniotic fluid; Hair regrowth; Decellularized biological product; XVIE
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: RBH-2026-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No