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

Integrative Skin Science and Research20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acne Vulgaris

Interventions

Multi-Step Botanical Skin Care RegimenOTHER

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

Eligibility

Sex: ALLMin age: 15 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Integrative Skin Science and Research

Sacramento, California, United States

Outcomes

Primary Outcomes

Total lesion count

Number of of inflammatory lesions, and open and closed comedones

Time frame: 8 weeks

Secondary Outcomes

Inflammatory lesion count

Number of inflammatory lesions

Time frame: 4 weeks

Inflammatory lesion count

Number of inflammatory lesions

Time frame: 8 weeks

Non-inflammatory lesion count

Number of open and closed comedones

Time frame: 4 weeks

Non-inflammatory lesion count

Number of open and closed comedones

Time frame: 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

Time frame: 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

Time frame: 8 weeks

Sebum excretion

Measure of skin sebum via sebumeter

Time frame: 4 weeks

Sebum excretion

Measure of skin sebum via sebumeter

Central Contacts

Jessica Maloh

CONTACT

9167502463 jessica@integrativeskinresearch.com

Data from ClinicalTrials.gov

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