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The goal of this study is to determine how safe and effective it is to improve hair growth using an active gummy treatment in women with self-perceived thinning hair.
The main aims of this trial are:
Participants who qualify will complete 5 visits after voluntary consent has been given. Participants will be given a 30-day supply of the gummies at each visit over a 4-month period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth.
In the study, participants will be asked to complete the following:
To qualify for this trial, participants must:
All photographs of the treatment area collected during the study will be used as study data.
All participants have the right to refuse further participation in the study at any time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xtressé Nutraceutical Supplement Active | Experimental | Other: Xtressé Nutraceutical Supplement Participants will receive a 30 day supply of gummy supplement 4 times during the study. Participants will take supplement daily and notate usage in log. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xtressé Hair Growth Gummies | Other | The nutraceutical supplement is powered by proprietary X-3 BioActive Blend and contains plant based extracts and regenerative compounds not commonly found in existing hair supplements. |
| 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 |
| Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis | Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after taking Xtressé™ Supplements. Measurements of density as measured hair per cm². | From enrollment to the end of treatment at 4 months |
| Within-subject increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis | Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after taking Xtressé™ Supplements. Measurements of follicular unit vellus/terminal ratio. | From enrollment to the end of treatment at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events associated with Treatment | Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events associated with the daily intake of supplement | From first treatment until the end of treatment at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant self-assessment of hair improvements collected via questionnaire | 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 Holdings, Inc. dba Xtressé | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Dermatology & Cosmetic Surgery | Maitland | Florida | 32751 | United States | ||
| Hair Medicine Institute |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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 |
| Alpharetta |
| Georgia |
| 30005 |
| United States |
| Kindred Hair and Skin | Marriottsville | Maryland | 21104 | United States |
| Root Hair Institute | Bellevue | Washington | 98004 | United States |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |