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

Part of paid clinical trials in Maitland, Florida.

Sponsor
Restore Biologics Holdings, Inc. dba Xtressé
Study ID
NCT07221773
Status
Enrolling By Invitation

Conditions

  • Hair Thinning

Eligibility Criteria

Sex
FEMALE
Age
28 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • XVIE — OTHER
    Acellular Allogenic Human Amniotic Fluid (hAF)

Study Details

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.

Key Dates

Start date
Sep 29, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

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 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Advanced Dermatology & Cosmetic SurgeryMaitlandFlorida32751-
Kindred Hair & Skin CenterMarriottsvilleMaryland21104-

Find similar trials in Maitland, FL

By research site
Advanced Dermatology & Cosmetic Surgery· Maitland, FLKindred Hair & Skin Center· Marriottsville, MD

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