Pilot Study to Evaluate the Efficacy and Safety of Xvie Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair

Official title

Pilot Study to Evaluate the Efficacy and Safety of Xvie (Human Amniotic Fluid Derived Nanoparticle Solution) Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair

Overview

The goal of this study is to determine how safe and effective it is to improve hair growth using XVIE solution applied on the scalp of women with self-perceived thinning hair. The main aims of this trial are: 1. To confirm using photographic analysis, changes in the quality, volume, and thickness of hair. 2. To gauge patient satisfaction with hair changes and application process. Participants who qualify will complete 5 to 6 visits after voluntary consent has been given. Participant's scalp will be numbed and the XVIE solution will be applied by microneedling. Photographs will be taken at each visit to measure changes in hair volume, thickness, and growth. Every participant will receive active treatment twice over the 4 month period.

Detailed description

XVIE is a proprietary, additive-free Human amniotic fluid (hAF) based therapy, containing a diverse array of bioactive molecules including growth factors, cytokines, hyaluronic acid, extracellular matrix proteins, and extracellular vesicles including exosomes. Extensive research have shown the ability of Xvie components to support cellular proliferation, angiogenesis, immune regulation, and matrix remodeling which has the potential to reverse underlying cause of hair loss.

In the study, participants will be asked to complete the following:

* Provide basic personal Information * Provide a Medical \& Surgical History * Follow study requirements to avoid certain medication and treatments * Complete all study visits and follow-up calls * Complete self-assessments and treatment use logs * Allow clinical assessment and photographic documentation of treatment.

All participants have the right to refuse further participation in the study at any time.

Interventions

• Other XVIE
  Acellular Allogenic Human Amniotic Fluid (hAF)

Primary outcome measures

• Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram Analysis [Time frame: From enrollment to the end of treatment at 4 months]
• Incidence of Adverse Events associated with Treatment [Time frame: From first treatment until the end of treatment at 4 months.]

Secondary outcome measures (1)

• Hair Density Changes measured by SOCAi [Time frame: From enrollment to the end of the study at 4 months]

Eligibility criteria

Inclusion criteria

• Women aged 28-65 years with self-perceived thinning hair (confirmed by an investigator).
• Ludwig Scale 1 to 2
• Fitzpatrick skin types I to VI.
• Ability and willingness to comply with the study protocol.
• Commitment to using effective contraception throughout the study if of childbearing potential.

Exclusion criteria

• Pregnancy, nursing, or recent initiation of hormone therapy.
• Change in other hair treatments within 3 months prior to the study.
• Known uncontrolled health conditions (e.g., poorly controlled diabetes, hypertension).
• History of hair or scalp disorders that could interfere with study results.
• History of keloid formation or poor wound healing
• History of bleeding and/or clotting disorders

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

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

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

Identifiers

NCT: NCT07221773 · XVIEP-2025-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗