Status:
ENROLLING_BY_INVITATION
Pilot Study to Evaluate the Efficacy and Safety of Xvie Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair
Lead Sponsor:
Restore Biologics Holdings, Inc. dba Xtressé
Conditions:
Hair Thinning
Eligibility:
FEMALE
28-65 years
Phase:
NA
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 t...
Detailed Description
XVIE is a proprietary, additive-free Human amniotic fluid (hAF) based therapy, containing a diverse array of bioactive molecules including growth factors, cytokines, hyaluronic acid, extracellular mat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07221773
Start Date
September 29 2025
End Date
June 1 2026
Last Update
November 6 2025
Active Locations (2)
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1
Advanced Dermatology & Cosmetic Surgery
Maitland, Florida, United States, 32751
2
Kindred Hair & Skin Center
Marriottsville, Maryland, United States, 21104