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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 men with androgenic alopecia.
The main aims of this trial are:
Participants who qualify will complete 3 visits after voluntary consent has been given. Participants will be given a 90-day supply of the gummies at visits 1 and 2 to cover the 6-month study 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:
Provide basic personal information (including date of birth, gender, race and ethnicity) Provide their medical/ surgical history and perform a medical exam (including but not limited to symptom-directed physical exam, skin type, vital signs, height, weight) Follow study rules such as avoiding certain medications and treatments Provide information on any medications, treatments or reactions that started after the study began Take gummy treatment daily and complete a treatment diary Allow clinical assessments and documentation of the treatment, such as photography, hair density measurements, any reactions or side effects
To qualify for this trial, participants must:
Be a male adult between 18 to 65 years of age Have hair loss in vertex region. Give voluntary written consent Be willing to follow study instructions and complete study requirements, including maintaining current diet and hair care routine, not using non-approved lotions and creams on the treatments areas Allow photographs of the front and top area of the scalp Confirm they are not sensitive to any of the study treatment ingredients
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 | Xtressé Nutraceutical Supplement Participants will receive a 90 day supply of the gummy supplement 2 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. The dosage is 2 gummies taken once per day. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 6 months of taking Xtressé™ Supplements. Measurements of density as measured hair per cm². | From enrollment to the end of treatment at 6 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 6 months of taking Xtressé™ Supplements. Measurements of follicular unit vellus/terminal ratio. | From enrollment to the end of treatment at 6 months |
| Hair Density Changes measured by SOCAi | Images will be captured using the the SOCAi system at baseline and Days 90, and 180, to evaluate hair density changes. | From enrollment to the end of treatment at 6 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 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant self-assessment of hair improvements collected via questionnaire | Observations and changes in hair loss graded on scale of 0 to 4 with 0 as no change and 4 as a very severe outcome. Observations are based on self-assessments completed at baseline and Day 180. | From enrollment to the end of study at 6 months |
Inclusion Criteria:
Exclusion Criteria:
Male sex at birth
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matt Leavitt, DO | Contact | 321-594-6851 | matt@xtresse.com |
| 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 |
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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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| Advanced Dermatology & Cosmetic Surgery | Port Orange | Florida | 32127 | United States |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |