A Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of a Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Other: Multi-Step Botanical Skin Care Regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 15 years of age until 45 years of age. The presence of mild to moderate acne based on investigator global assessment. Exclusion Criteria: The presence of severe acne as noted by the investigator global assessment. Those with a nut allergy. Those who are unwilling to discontinue oral probiotic-based supplementation to meet the washout criteria prior to enrolling. Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide to meet the washout criteria prior to enrolling. Individuals who are unwilling to discontinue vitamin E containing supplements during the washout and intervention. Individuals who have been on an oral antibiotic for acne within the previous 1 month. Individuals who are pregnant or breastfeeding. Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study. Oral supplementation that has nuts in it. Use of isotretinoin within the three months prior to joining the study. Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-Step Botanical Skin Care Regimen<br>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. | Other: Multi-Step Botanical Skin Care Regimen<br>* The intervention includes 7 different topical products: Cleanser Toner Oil Control Cream Exfoliating Facial Scrub Clay Mask Acne Spot Treatment Body Scrub<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total lesion count | Number of of inflammatory lesions, and open and closed comedones | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory lesion count | Number of inflammatory lesions | 4 weeks | 
| Inflammatory lesion count | Number of inflammatory lesions | 8 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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botanical, microbiome, skin care