Clinical trial NCT05271487: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Acne Vulgaris
Keywords: botanical
microbiome
skin care
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Codex Beauty Corporation
First posted: 2022-03-09
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Total lesion count
timeFrame: 8 weeks
Secondary outcomes:
measure: Inflammatory lesion count
timeFrame: 4 weeks
measure: Inflammatory lesion count
timeFrame: 8 weeks
measure: Non-inflammatory lesion count
timeFrame: 4 weeks
measure: Non-inflammatory lesion count
timeFrame: 8 weeks
measure: Investigator global assessment (IGA) of acne
timeFrame: 4 weeks
measure: Investigator global assessment (IGA) of acne
timeFrame: 8 weeks
measure: Sebum excretion
timeFrame: 4 weeks
measure: Sebum excretion
timeFrame: 8 weeks
measure: Gut microbiome assessment
timeFrame: 4 weeks
measure: Gut microbiome assessment
timeFrame: 8 weeks
measure: Skin microbiome diversity
timeFrame: 4 weeks
measure: Skin microbiome diversity
timeFrame: 8 weeks
measure: Positive and Negative Affect Schedule (PANAS-SF)
timeFrame: 4 weeks
measure: Positive and Negative Affect Schedule (PANAS-SF)
timeFrame: 8 weeks
measure: Diurnal Cortisol Slope
timeFrame: 4 weeks
measure: Diurnal Cortisol Slope
timeFrame: 8 weeks
measure: Salivary Sex Hormone Levels
timeFrame: 4 weeks
measure: Salivary Sex Hormone Levels
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
References: