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

NCT07221773 | Enrolling By Invitation

• 1 other identifier: XVIEP-2025-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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. 1.To confirm using photographic analysis, changes in the quality, volume, and thickness of hair.
2. 2.To gauge patient satisfaction with hair changes and application process.

Conditions

Hair Thinning

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram Analysis

  Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after multiple treatments with XVIE

  From enrollment to the end of treatment at 4 months

• Incidence of Adverse Events associated with Treatment

  Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events that occur during the trial within 30 days of microneedling treatment.

  From first treatment until the end of treatment at 4 months.

Secondary Outcomes (1)

• Hair Density Changes measured by SOCAi

  From enrollment to the end of the study at 4 months

Other Outcomes (2)

• Participant self-assessment of hair improvements collected via questionnaires

  From enrollment to the end of study at 4 months

• Investigator assessment of changes in hair quality

  From baseline to the end of the study at 4 months

Study Arms (1)

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

EXPERIMENTAL

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.

Other: XVIE

Interventions

XVIE OTHER

Acellular Allogenic Human Amniotic Fluid (hAF)

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

Eligibility Criteria

• Age: 28 Years - 65 Years
• Gender Eligibility Details: Female sex at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Restore Biologics Holdings, Inc. dba Xtressé: lead

Study Sites (2)

Advanced Dermatology & Cosmetic Surgery

Maitland, Florida, 32751, United States

Location

Kindred Hair & Skin Center

Marriottsville, Maryland, 21104, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Study Officials

• Melissa Y Rayner, MS

  Restore Biologics Holding, Inc dba Xtressé

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label study evaluating safety and efficacy

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: October 28, 2025
• Study Start: September 29, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)