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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:
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:
All participants have the right to refuse further participation in the study at any time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XVIE microneedling process applied to the scalp twice over a 4 month period. | Experimental | XVIE is proprietary, additive-free human amniotic fluid derived product that contains an diverse array of bioreactive molecules including growth factors, cytokines, ECM proteins, exosomes, and hyaluronic acid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XVIE | Other | Acellular Allogenic Human Amniotic Fluid (hAF) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | From first treatment until the end of treatment at 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of the study at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant self-assessment of hair improvements collected via questionnaires | Observations and changes noted in hair loss graded on scale of 0 to 4 with 0 as no change and 4 as a very severe outcome. Observations and changes noted in quality of life based on hair loss, with outcomes graded between extremely effected to not at all. Observations are based on self-assessments completed at baseline and Day 120. |
Inclusion Criteria:
Exclusion Criteria:
Female sex at birth
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Y Rayner, MS | Restore Biologics Holding, Inc dba Xtressé | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Dermatology & Cosmetic Surgery | Maitland | Florida | 32751 | United States | ||
| Kindred Hair & Skin Center |
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Open label study evaluating safety and efficacy
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| From enrollment to the end of study at 4 months |
| Investigator assessment of changes in hair quality | Changes noted in hair quality graded on a scale of -3 to +3, with -3 as decreased/significantly worsened, 0 indicates no change, and +3 as increased/significantly improved | From baseline to the end of the study at 4 months |
| Marriottsville |
| Maryland |
| 21104 |
| United States |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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