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.
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 matrix proteins, and extracellular vesicles including exosomes. Extensive research have shown the ability of Xvie components to support cellular proliferation, angiogenesis, immune regulation, and matrix remodeling which has the potential to reverse underlying cause of hair loss. In the study, participants will be asked to complete the following: * Provide basic personal Information * Provide a Medical \& Surgical History * Follow study requirements to avoid certain medication and treatments * Complete all study visits and follow-up calls * Complete self-assessments and treatment use logs * Allow clinical assessment and photographic documentation of treatment. All participants have the right to refuse further participation in the study at any time.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Acellular Allogenic Human Amniotic Fluid (hAF)
Advanced Dermatology & Cosmetic Surgery
Maitland, Florida, United States
Kindred Hair & Skin Center
Marriottsville, Maryland, United States
Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram Analysis
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after multiple treatments with XVIE
Time frame: From enrollment to the end of treatment at 4 months
Incidence of Adverse Events associated with Treatment
Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events that occur during the trial within 30 days of microneedling treatment.
Time frame: From first treatment until the end of treatment at 4 months.
Hair Density Changes measured by SOCAi
Images will be captured using the the SOCAi system at baseline and Days 30, 60, 90, and 120, to evaluate hair density changes.
Time frame: From enrollment to the end of the study at 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.