XVIE to Treat Androgenetic Alopecia (AGA)

NCT07482423 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: RBH-2026-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Androgenetic Alopecia

Keywords

Androgenetic alopecia; Pattern hair loss; Extracellular vesicles; Human amniotic fluid; Intradermal injection; Hair regrowth; Decellularized biological product; XVIE

Outcome Measures

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.

  Baseline through Day 180

Secondary Outcomes (7)

• Change in Total Area Hair Count (TAHC) as measured by Canfield HairMetrix Automated Imaging System

  Baseline, Month 3 (Day 90), Month 6 (Day 180)

• Change in hair density (hairs/cm²) as measured by Canfield HairMetrix Automated Imaging System

  Baseline, Month 3 (Day 90), Month 6 (Day 180)

• Change in mean hair shaft diameter (mm) as measured by Canfield HairMetrix Automated Imaging System

  Baseline, Month 3 (Day 90), Month 6 (Day 180)

• Change in global scalp coverage percentage as measured by SoCAI Global HairMap Imaging Platform

  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

  Month 3 (Day 90), Month 6 (Day 180)

Other Outcomes (3)

• Change in vellus-to-terminal hair ratio as measured by hair caliber distribution analysis using Canfield HairMetrix Automated Imaging System

  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

  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

  Month 3 (Day 90), Month 6 (Day 180)

Study Arms (2)

XVIE

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

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.

XVIE

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Restore Biologics Holdings, Inc. dba Xtressé: lead

Study Sites (2)

Advanced Dermatology and Cosmetic Surgery

Orlando, Florida, 32827, United States

Location

Kindred Hair & Skin Center

Marriottsville, Maryland, 21104, United States

Location

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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.

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• 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.

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• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Alopecia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Trillitye Paullin, PhD

CONTACT

855-284-8266; trill@xtresse.com

Melissa Rayner

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy and product processing staff are unblinded and separated from site staff involved in subject assessment. All other personnel, including subjects, investigators, and outcomes assessors, are blinded to treatment assignment. XVIE and placebo are supplied in identical vials with identical packaging, labeling, and administration schedule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two parallel arms: active treatment (XVIE) and placebo control (sterile saline), administered identically via intradermal scalp injection at Day 0 and Day 90.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)