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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
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
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