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| Name | Class |
|---|---|
| Codex Beauty Corporation | UNKNOWN |
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The purpose of this study is to analyze changes in acne and changes in the gut and skin microbiome with the use of a multi-step botanical skin care regimen in those with mild to moderate acne.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-Step Botanical Skin Care Regimen | Experimental | The patient will be provided with and instructed to use a cleanser, toner, oil control cream, exfoliating facial scrub, clay mask, acne spot treatment, and body scrub for the duration of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-Step Botanical Skin Care Regimen | Other | The intervention includes 7 different topical products:
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| Measure | Description | Time Frame |
|---|---|---|
| Total lesion count | Number of of inflammatory lesions, and open and closed comedones | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory lesion count | Number of inflammatory lesions | 4 weeks |
| Inflammatory lesion count | Number of inflammatory lesions | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Maloh | Contact | 9167502463 | jessica@integrativeskinresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin Science and Research | Sacramento | California | 95819 | United States |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Non-inflammatory lesion count | Number of open and closed comedones | 4 weeks |
| Non-inflammatory lesion count | Number of open and closed comedones | 8 weeks |
| Investigator global assessment (IGA) of acne | Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne | 4 weeks |
| Investigator global assessment (IGA) of acne | Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne | 8 weeks |
| Sebum excretion | Measure of skin sebum via sebumeter | 4 weeks |
| Sebum excretion | Measure of skin sebum via sebumeter | 8 weeks |
| Gut microbiome assessment | Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample | 4 weeks |
| Gut microbiome assessment | Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample | 8 weeks |
| Skin microbiome diversity | Shift in Shannon diversity of the skin microbiome | 4 weeks |
| Skin microbiome diversity | Shift in Shannon diversity of the skin microbiome | 8 weeks |
| Positive and Negative Affect Schedule (PANAS-SF) | Survey assessing positive and negative mood states. Scores range from 10 to 50 with higher scores representing positive affect | 4 weeks |
| Positive and Negative Affect Schedule (PANAS-SF) | Survey assessing positive and negative mood states. Scores range from 10 to 50 with higher scores representing positive affect | 8 weeks |
| Diurnal Cortisol Slope | 4 salivary cortisol collections to assess diurnal slope | 4 weeks |
| Diurnal Cortisol Slope | 4 salivary cortisol collections to assess diurnal slope | 8 weeks |
| Salivary Sex Hormone Levels | 1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS | 4 weeks |
| Salivary Sex Hormone Levels | 1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS | 8 weeks |