Hair Thinning
Conditions
Keywords
hair loss, hair thinning, Alopecia, thin hair, thinning hair
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 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.
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 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.
Interventions
OTHERXVIE
Acellular Allogenic Human Amniotic Fluid (hAF)
Sponsors
Restore Biologics Holdings, Inc. dba Xtressé
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label study evaluating safety and efficacy
Eligibility
Sex/Gender
FEMALE
Age
28 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram Analysis | From enrollment to the end of treatment at 4 months | Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after multiple treatments with XVIE |
| Incidence of Adverse Events associated with Treatment | From first treatment until the end of treatment at 4 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hair Density Changes measured by SOCAi | From enrollment to the end of the study at 4 months | Images will be captured using the the SOCAi system at baseline and Days 30, 60, 90, and 120, to evaluate hair density changes. |
Countries
United States
Contacts
STUDY_DIRECTORMelissa Y Rayner, MS
Restore Biologics Holding, Inc dba Xtressé
Outcome results
None listed