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The goal of this study is to determine how safe and effective it is to improve hair growth by applying a serum daily on the scalp of men and women with thinning hair.
The main aims of this trial are:
Participants who qualify will complete 7 visits after voluntary consent has been given. Participants will be given 9 bottles of serum to use during the study. The product will be applied daily over a 9-month period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth. Participants will complete a survey in the middle and at the end of the study.
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 |
|---|---|---|---|
| Single Group | Experimental | Xtresse Concentrate Serum Participants will receive 4-month supply of serum. They will apply serum to their scalp daily and notate usage log. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xtresse Serum | Other | The concentrate serum 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 |
|---|---|---|
| Increase in hair density assessed by Canfield HairMetrix® Phototrichogram Analysis | Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months of application of Xtressé™ serum. Measurements of density as measured hair per cm². | From enrollment to end of treatment at 4 months |
| Hair Density changes measured by SOCAi | Images will be captures using 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 |
| 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 applying Xtressé™ Serum. 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 application of serum | From first treatment until the end of treatment at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient self-assessment of hair improvements collected via questionnaire | Observations and changes in hair conditions seen over the course of using Xtresse Serum. It is graded on scale of 0 to 7 with 0 as greatly worsened hair conditions (worser outcome), 4 is no change in hair conditions and 7 is greatly improved hair conditions (a better outcome). Observations are based on self-assessments completed at baseline and Day 120. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Rayner, MS | Restore Biologics Holdings, Inc dba Xtresse | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Dermatology & Cosmetic Surgery | Maitland | Florida | 32751 | United States | ||
| Kindred Hair and Skin Center |
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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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| From enrollment to the end of study at 4 months |
| Marriottsville |
| Maryland |
| 21104 |
| United States |
| Root Hair Institute | Bellevue | Washington | 98004 | United States |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |