A Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome
Primary Purpose
Acne Vulgaris
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-Step Botanical Skin Care Regimen
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring botanical, microbiome, skin care
Eligibility Criteria
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.
Sites / Locations
- Integrative Skin Science and Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multi-Step Botanical Skin Care Regimen
Arm Description
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.
Outcomes
Primary Outcome Measures
Total lesion count
Number of of inflammatory lesions, and open and closed comedones
Secondary Outcome Measures
Inflammatory lesion count
Number of inflammatory lesions
Inflammatory lesion count
Number of inflammatory lesions
Non-inflammatory lesion count
Number of open and closed comedones
Non-inflammatory lesion count
Number of open and closed comedones
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
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
Sebum excretion
Measure of skin sebum via sebumeter
Sebum excretion
Measure of skin sebum via sebumeter
Gut microbiome assessment
Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample
Gut microbiome assessment
Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample
Skin microbiome diversity
Shift in Shannon diversity of the skin microbiome
Skin microbiome diversity
Shift in Shannon diversity of the skin microbiome
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
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
Diurnal Cortisol Slope
4 salivary cortisol collections to assess diurnal slope
Diurnal Cortisol Slope
4 salivary cortisol collections to assess diurnal slope
Salivary Sex Hormone Levels
1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS
Salivary Sex Hormone Levels
1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS
Full Information
NCT ID
NCT05271487
First Posted
February 25, 2022
Last Updated
March 8, 2022
Sponsor
Integrative Skin Science and Research
Collaborators
Codex Beauty Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05271487
Brief Title
A Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome
Official Title
The Effects of a Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 7, 2022 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Integrative Skin Science and Research
Collaborators
Codex Beauty Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
botanical, microbiome, skin care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multi-Step Botanical Skin Care Regimen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Multi-Step Botanical Skin Care Regimen
Intervention Description
The intervention includes 7 different topical products:
Cleanser
Toner
Oil Control Cream
Exfoliating Facial Scrub
Clay Mask
Acne Spot Treatment
Body Scrub
Primary Outcome Measure Information:
Title
Total lesion count
Description
Number of of inflammatory lesions, and open and closed comedones
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Inflammatory lesion count
Description
Number of inflammatory lesions
Time Frame
4 weeks
Title
Inflammatory lesion count
Description
Number of inflammatory lesions
Time Frame
8 weeks
Title
Non-inflammatory lesion count
Description
Number of open and closed comedones
Time Frame
4 weeks
Title
Non-inflammatory lesion count
Description
Number of open and closed comedones
Time Frame
8 weeks
Title
Investigator global assessment (IGA) of acne
Description
Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne
Time Frame
4 weeks
Title
Investigator global assessment (IGA) of acne
Description
Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne
Time Frame
8 weeks
Title
Sebum excretion
Description
Measure of skin sebum via sebumeter
Time Frame
4 weeks
Title
Sebum excretion
Description
Measure of skin sebum via sebumeter
Time Frame
8 weeks
Title
Gut microbiome assessment
Description
Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample
Time Frame
4 weeks
Title
Gut microbiome assessment
Description
Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample
Time Frame
8 weeks
Title
Skin microbiome diversity
Description
Shift in Shannon diversity of the skin microbiome
Time Frame
4 weeks
Title
Skin microbiome diversity
Description
Shift in Shannon diversity of the skin microbiome
Time Frame
8 weeks
Title
Positive and Negative Affect Schedule (PANAS-SF)
Description
Survey assessing positive and negative mood states. Scores range from 10 to 50 with higher scores representing positive affect
Time Frame
4 weeks
Title
Positive and Negative Affect Schedule (PANAS-SF)
Description
Survey assessing positive and negative mood states. Scores range from 10 to 50 with higher scores representing positive affect
Time Frame
8 weeks
Title
Diurnal Cortisol Slope
Description
4 salivary cortisol collections to assess diurnal slope
Time Frame
4 weeks
Title
Diurnal Cortisol Slope
Description
4 salivary cortisol collections to assess diurnal slope
Time Frame
8 weeks
Title
Salivary Sex Hormone Levels
Description
1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS
Time Frame
4 weeks
Title
Salivary Sex Hormone Levels
Description
1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Maloh
Phone
9167502463
Email
jessica@integrativeskinresearch.com
Facility Information:
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Maloh
Phone
916-750-2463
Email
jessica@integrativeskinresearch.com
First Name & Middle Initial & Last Name & Degree
Raja Sivamani, MD MS AP
12. IPD Sharing Statement
Plan to Share IPD
No
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A Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome
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