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

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.

NCT Number	NCT07221773
Lead Sponsor	Restore Biologics Holdings, Inc. dba Xtressé
Conditions	Hair Thinning
Enrollment	15 participants
Start Date	2025-09-29
Primary Completion	2026-12 (estimated)
Study Completion	2027-02 (estimated)
Updated on ClinicalTrials.gov	2026-06-08