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

NCT ID: NCT07221773

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-29
• Study Completion Date: 2026-06-30

Brief Summary

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.

Conditions

Hair Thinning

Keywords

hair loss; hair thinning; Alopecia; thin hair; thinning hair

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XVIE microneedling process applied to the scalp twice over a 4 month period.

XVIE is proprietary, additive-free human amniotic fluid derived product that contains an diverse array of bioreactive molecules including growth factors, cytokines, ECM proteins, exosomes, and hyaluronic acid.

Group Type: EXPERIMENTAL

XVIE

Intervention Type: OTHER

Acellular Allogenic Human Amniotic Fluid (hAF)

Interventions

XVIE

Acellular Allogenic Human Amniotic Fluid (hAF)

Intervention Type: OTHER

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

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Restore Biologics Holdings, Inc. dba Xtressé

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Y Rayner, MS

Role: STUDY_DIRECTOR

Restore Biologics Holding, Inc dba Xtressé

Locations

Advanced Dermatology & Cosmetic Surgery

Maitland, Florida, United States

Kindred Hair & Skin Center

Marriottsville, Maryland, United States

Countries

United States

Other Identifiers

XVIEP-2025-001

Identifier Type: -

Identifier Source: org_study_id