Acne Vulgaris
Conditions
Keywords
botanical, microbiome, skin care
Brief summary
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.
Interventions
OTHERMulti-Step Botanical Skin Care Regimen
The intervention includes 7 different topical products: 1. Cleanser 2. Toner 3. Oil Control Cream 4. Exfoliating Facial Scrub 5. Clay Mask 6. Acne Spot Treatment 7. Body Scrub
Sponsors
Codex Beauty Corporation
Integrative Skin Science and Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total lesion count | 8 weeks | Number of of inflammatory lesions, and open and closed comedones |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory lesion count | 4 weeks | Number of inflammatory lesions |
| Non-inflammatory lesion count | 4 weeks | Number of open and closed comedones |
| Investigator global assessment (IGA) of acne | 4 weeks | Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne |
| Sebum excretion | 4 weeks | Measure of skin sebum via sebumeter |
| Gut microbiome assessment | 4 weeks | Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample |
| Skin microbiome diversity | 4 weeks | Shift in Shannon diversity of the skin microbiome |
| Positive and Negative Affect Schedule (PANAS-SF) | 4 weeks | Survey assessing positive and negative mood states. Scores range from 10 to 50 with higher scores representing positive affect |
| Diurnal Cortisol Slope | 4 weeks | 4 salivary cortisol collections to assess diurnal slope |
| Salivary Sex Hormone Levels | 4 weeks | 1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS |
Countries
United States
Contacts
Primary ContactJessica Maloh
Outcome results
None listed