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| Name | Class |
|---|---|
| ALS Beauty and Personal Care | INDUSTRY |
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The objective of this study is to assess the effectiveness of a novel dietary ingredient containing biotin and silicon for promoting hair growth and improving skin's appearance with six months of continuous daily usage among healthy adults.
Scientific problem:
Hair thinning and hair loss are problems that affect both men and women. A variety of diet, lifestyle, life-stage, ethnicity/race, and genetic factors contribute to the thinning and loss of hair. While hair loss is not a condition that is life-threatening, it is life-impacting. Hair loss negatively affects confidence and is associated with decline in quality of life While FDA-approved treatments do exist, access or ease of use may be difficult, or use limited to men. Ingredients like biotin, silicon, and herbals have been marketed for hair, skin, and nail benefits. The studies on their benefits are equivocal, requiring continued research investments to guide evidence-based recommendations for use. The availability of an oral supplement that is safe and effective for everyday use may present a new option for men and women concerned with hair thinning or hair loss.
Specific aims The objective of this randomized, triple-blind, placebo-controlled study is to assess the effectiveness of a novel dietary ingredient formulated with 10 mg of biotin and 10 mg of silicon for improving the appearance of hair and skin in a generally healthy adult population. The primary aim of this study will be to evaluate the impact of daily use on hair growth. In addition, the impact of supplementation on other hair and skin parameters will be evaluated. The study will include both analytical measures and a subjective questionnaire in order to connect analytical outcomes with observable changes in appearance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active capsules | Active Comparator | Dietary ingredient standardized to deliver 10 mg of biotin and 10 mg of silicon per serving (1 capsule/serving). |
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| Placebo capsules | Placebo Comparator | The placebo comparator contains only inert ingredients (1 capsule/serving) |
|
| open label | Other | Open-label arm that will involve men who only receive the active dietary ingredient capsules. This arm will run in parallel with the blinded study conducted in women. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biotin and silicon | Dietary Supplement | The active ingredient contains a standardized level of biotin (10 mg) and silicon (10 mg) per serving. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hair growth and hair density | Changes in the appearance of hair growth and hair thickness [bioinstrumental method; image analzysis using FotoFinder Medicam 1000] | baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Appearance of global final lines and wrinkles | Changes in the appearance of facial fine lines and wrinkles [assessed simultaneously using Canfield VISIA CR System; images evaluated using Vaestro Image Analysis Toolkit from Canfield] | baseline, 3 months, 6 months |
| Skin (facial) firmness |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Assessment Questionnaire | Self-Assessment - Please answer the following questions by circling the response that best describes any changes you have noticed since starting this study (from +3 (greatly improved), +2 (moderately improved), +1 (slightly improved), 0 (no change), -1 (slightly worsened), -2 (moderately worsened), -3 (greatly worsened)
Please provide any personal experience you want to share. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordan DeSantis, BS, MHI | Contact | 602-277-1154 | jordan.desantis@alsglobal.com | |
| Brochelle Yazzie, BS | Contact | 602-277-1154 | brochelle.yazzie@alsgobal.com |
| Name | Affiliation | Role |
|---|---|---|
| Jordan DeSantis | ALS Beauty and Personal Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALS Beauty and Personal Care | Recruiting | Phoenix | Arizona | 85012 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Kalman, D. S., & Hewlings, S. J. (2021). A Randomized Double-Blind Evaluation of a Novel Biotin and Silicon Ingredient Complex on the Hair and Skin of Healthy Women. Journal of Clinical & Experimental Dermatology Research, 12(1), 1-5. |
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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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| ID | Term |
|---|---|
| D001710 | Biotin |
| D012825 | Silicon |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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This is a six (6) month triple-blind, randomized, placebo-controlled study in women with self-perceived hair thinning/loss, with a six (6) month open-label arm in men using only the active product that will be conducted in parallel with the intervention study in women.
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The primary intervention will utilize anonymized/coded products - anonymized/coded by the manufacturer and product codes only kept by supply chain and not directly maintained by study sponsor. The clinical test site will re-code the products, so the study will actually be triple-blind.
Open-label products will be made with the active ingredients and this product will be labeled as an active - with no masking of identity to study sponsor, clinical site, or study participants.
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| Placebo | Dietary Supplement | Inert ingredients only |
|
Changes in firmness of facial skin [ Cutometer MPA 580] -measured in mm |
| baseline, 3 months, 6 months |
| Skin (facial) elasticity | Changes in facial skin elasticity [Cutometer MPA 580] - measured in % | baseline, 3 months, 6 months |
| Skin hydration | Changes in the water content of human skin [changes in skin conductance (AU-Arbitrary Units) using Corneometer CM 825] | baseline, 3 months, 6 months |
| Skin texture-Skin Smoothness | Changes in skin texture [measured optically using VisioScan VC 98] - Evaluated using SELS (Surface Evaluation of the Living Skin)- SEsm index-AU- Arbitrary Units | baseline, 3 months, 6 months |
| Skin texture-Skin Roughness | Changes in skin texture [measured optically using VisioScan VC 98] - Evaluated using SELS (Surface Evaluation of the Living Skin);- SEr index-AU- Arbitrary Units | baseline, 3 months, 6 months |
| baseline, 3 months, 6 months |
| Plasma biotin status | Changes in plasma biotin status (ng/mL) | baseline, 6 months |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D058955 | Metalloids |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |