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| Name | Class |
|---|---|
| Restore Biologics Holdings, Inc. dba Xtressé | INDUSTRY |
| Xtressé (TM) | UNKNOWN |
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The goal of this clinical trial is to test how safe and effective it is to improve hair growth using an active gummy and serum combination treatment when compared to an inactive treatment combination in women with self-perceived thinning hair.
The main questions this trial aims to answer are:
Participants who qualify will be asked to complete 6 to 7 visits after voluntarily consent has been given. The study is divided into two parts. In Part A participants will be randomly given either active or inactive treatment to use over 3 months. After 3 months, all participants will enter Part B of the study and will be given active treatment to use over the final 6 months of the study.
In the study, participants will be asked to complete the following:
To qualify for this trial, participants must:
A relatively small area will be shaved off-center and top of the scalp for a dot-tattoo placement and this marked area will be used for clinical assessments throughout the study.
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 |
|---|---|---|---|
| Intervention Group - Part A and Part B | Active Comparator | 43 subjects will be randomized to this group and will receive Xtressé™ supplements + serum during the double-blinded Part A and open-label Part B of the study. |
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| Placebo Group- Part A | Placebo Comparator | 42 subjects will be randomized to this group and will receive Placebo supplements and serum in only Part A of the study. |
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| Placebo Group- Part B | Active Comparator | 42 subjects will enter the open-labelled Part B of the study and will receive Xtressé™ supplements + serum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Comparator- Xtressé™ Supplement and Serum | Dietary Supplement | Participants will receive 3 month supplies 3 times during the study. Participants will apply serum and take supplements daily. Participants in the Intervention group will receive Xtressé™ Supplements and Serum in Part A and Part B of the study. Participants in the Placebo Group will receive Xtressé™ Supplement and Serum in Part B of the study only. |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in hair density (hairs per cm²) measured as the within-subject change from baseline to Month 3, assessed via Canfield HairMetrix® phototrichogram analyses. | Quantitative hair measurements calculated by analyzing the participants digital images. | an average of 3 months |
| Increase in hair density (hairs per cm²) Measured as the within-subject change from baseline to Month 9, assessed via Canfield HairMetrix® phototrichogram analyses. | Quantitative hair measurements calculated by analyzing the participants digital images. | Up to 9 months |
| Participant self-assessment of hair growth and satisfaction, collected via validated questionnaires. | Observations and changes noted in hair loss graded on a scale of 0 to 4, with 0 as none and 4 as a very severe outcome. Observations and changes noted in quality of life based on hair loss, outcomes graded between extremely affected and not at all. | Up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in hair density as measured by SOCAi | Changes to the appearance of hair will be captured using the SOCAi system. | Up to 9 months |
| Improvements in hair quality (e.g., thickness, strength) and volume, evaluated by blinded investigator assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark S. Nestor, MD, PhD | Contact | 305-933-6716 | info@centerforclinicalandcosmeticresearch.com |
| Name | Affiliation | Role |
|---|---|---|
| Danielle Leavitt | Restore Biologics Holdings, Inc. dba Xtressé | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Wellness Dermatology | Recruiting | Birmingham | Alabama | 35209 | United States |
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Double-blinded in Part A followed by Open-label in Part B of the study.
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| Placebo Comparator- Placebo Supplement and Serum | Dietary Supplement | Participants will receive 3 month supplies 3 times during the study. Participants will apply serum and take supplements daily. Participants in the Placebo Group will receive Placebo Supplement and Serum in Part A of the study only. |
|
Observations and changes noted in hair quality graded on a scale of -3 to +3, with -3 as greatly worsened/ decreased, 0 as no change and +3 as significantly increased/ improved. |
| Up to 9 months |
| Center for Clinical and Cosmetic Research | Recruiting | Aventura | Florida | 33180 | 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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