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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Other: Multi-Step Botanical Skin Care Regimen

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Maloh; Phone Number: 9167502463; Email: jessica@integrativeskinresearch.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95819
      • Integrative Skin Science and Research
      • Contact: Jessica Maloh; Phone Number: 916-750-2463; Email: jessica@integrativeskinresearch.com
      • Principal Investigator: Raja Sivamani, MD MS AP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Multi-Step Botanical Skin Care Regimen; 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; The intervention includes 7 different topical products: Cleanser; Toner; Oil Control Cream; Exfoliating Facial Scrub; Clay Mask; Acne Spot Treatment; Body Scrub

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Codex Beauty Corporation

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 7, 2022
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (ACTUAL): March 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: microbiome; skin care; botanical
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: CB_Acne_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No