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

Not Applicable

• Conditions: Acne Vulgaris

• Registration Number: NCT05271487
• Lead Sponsor: Integrative Skin Science and Research

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-25
• Study Start: 2022-03-07
• Study First Submitted QC: 2022-03-08
• Last Update Submitted: 2022-03-08
• Study First Posted: 2022-03-09
• Last Update Posted: 2022-03-09
• Primary Completion: 2022-07-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total lesion count	8 weeks	Number of of inflammatory lesions, and open and closed comedones

Secondary Outcome Measures

Name	Time	Method
Sebum excretion	8 weeks	Measure of skin sebum via sebumeter
Investigator global assessment (IGA) of acne	8 weeks	Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne
Gut microbiome assessment	8 weeks	Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample
Inflammatory lesion count	8 weeks	Number of inflammatory lesions
Non-inflammatory lesion count	8 weeks	Number of open and closed comedones
Skin microbiome diversity	8 weeks	Shift in Shannon diversity of the skin microbiome
Positive and Negative Affect Schedule (PANAS-SF)	8 weeks	Survey assessing positive and negative mood states. Scores range from 10 to 50 with higher scores representing positive affect
Diurnal Cortisol Slope	8 weeks	4 salivary cortisol collections to assess diurnal slope
Salivary Sex Hormone Levels	8 weeks	1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS

Trial Locations

Locations (1)

Integrative Skin Science and Research; 🇺🇸 Sacramento, California, United States