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| Name | Class |
|---|---|
| Sytheon Ltd. | INDUSTRY |
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The purpose of this study is to assess the use of oral Terminalia chebula fruit extract on the gut microbiome and skin biophysical properties. The fruit is commonly used for skin treatments in India. It is thought to have antioxidant properties, reduce inflammation and affect the microorganisms in the gut.
The information the investigators will learn from this study may indicate how and if oral dosing can affect the skin and gut microbiome. This may lead to an improved understanding of the skin and determine whether these oral products are effective for improving the skin's appearance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Placebo, Topical Placebo | Placebo Comparator | Oral Placebo, Topical Placebo on both forearms and dorsal hands |
|
| Oral Placebo, Topical TC | Experimental | Oral Placebo, Topical TC on both forearms and dorsal hands |
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| Oral TC, Topical Placebo | Experimental | Oral TC, Topical Placebo on both forearms and dorsal hands |
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| Oral TC, Topical TC | Experimental | Oral TC, Topical TC on both forearms and dorsal hands |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terminalia Chebula fruit extract | Dietary Supplement | Oral TC fruit extract supplement taken by mouth twice per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stool microbiome diversity | Stool is collected and analyzed for species of bacteria through nucleic acid sequencing. | 8 weeks |
| Sebum production | Delfin Sebumeter: 0-150 micrograms/cm^2 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Transepidermal water loss | Delfin Vapometer 0-300g/m^2h | 8 weeks |
| Facial pigmentation | SkinColorCatchRGB range: 25-246 per channel | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raja K Sivamani, MD | Integrative Skin Science and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin Science and Research | Sacramento | California | 95815 | United States |
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| ID | Term |
|---|---|
| C000713171 | chebulae fruit |
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Double-blinded placebo controlled
| Placebo | Dietary Supplement | Oral placebo taken by mouth twice per day |
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| Topical Terminalia Chebula | Other | Applied to both forearms and dorsal hands |
|
| Topical Placebo | Other | Applied to both forearms and dorsal hands |
|
| Facial redness - Device Based | SkinColorCatch colorimeter RGB range: 25-246 per channel | 8 weeks |
| Facial wrinkles | BTBP Clarity Mini 3D camera: Wrinkle severity (depth and width measurement in unitless units) | 8 weeks |
| Facial shine | BTBP Clarity Mini 3D: (Surface reflection measured in unitless units) | 8 weeks |
| hand and arm pigmentation | SkinColorCatch colorimeter RGB range: 25-246 per channel | 8 weeks |
| hand and arm redness | SkinColorCatch colorimeter RGB range: 25-246 per channel | 8 weeks |
| Tolerability of Topical Products | Subjective Tolerability Questionnaire is collected | 8 weeks |
| Skin typing questionnaire | Subjective Questionnaire is collected | 8 weeks |
| Ayurvedic typing questionnaire | Subjective Questionnaire is collected | 8 weeks |
| Salivary diurnal cortisol slope | 4 point salivary cortisol is measured over the course of a day | 8 weeks |
| Skin Hydration | Delfin MoisturemeterSC 0-150 | 8 weeks |
| Facial Redness - Image Based | BTBP Clarity Mini 3D camera | 8 weeks |