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ENROLLING BY INVITATION
NCT07221773
NA

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

Sponsor: Restore Biologics Holdings, Inc. dba Xtressé

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

28 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2025-09-29

Completion Date

2026-06

Last Updated

2025-11-06

Healthy Volunteers

No

Conditions

Interventions

OTHER

XVIE

Acellular Allogenic Human Amniotic Fluid (hAF)

Locations (2)

Advanced Dermatology & Cosmetic Surgery

Maitland, Florida, United States

Kindred Hair & Skin Center

Marriottsville, Maryland, United States