Clinical trial NCT04596748: Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris
Official title: Prospective Randomized Double-Blind Placebo-Controlled Study of Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acne Vulgaris
Keywords: acne vulgaris
skin
dermatology
acne
microbiome
probiotics
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Microbiome labs
First posted: 2020-10-22
Enrollment: 70
Sex: ALL
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized, placebo-controlled
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how probiotics affect sebum production and gut health in those with acne vulgaris.

Detailed description: Probiotics have been shown in previous pilot studies to be helpful in acne and this study aims to examine how the gut microbiome and skin biophysical properties are shifted in those with acne vulgaris. In particular, this study will assess the influence of oral spore based probiotics on the skin sebum production and will assess how probiotics influence the gut microbiome and the blood levels of short chain fatty acids.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 13-45
* Subjects with acne vulgaris as diagnosed by a board-certified dermatologist,having mild-moderate acne on the face with an IGA score of 2-3 and 10+ inflammatory lesions on face and 15+ total lesions.
* Subjects should experience new acne lesions on a recurrent basis within last 6 months
* Must be willing to comply with all protocol requirements
* Must be willing to have flash photo facial images taken with the imaging systems
* Males must be willing to shave any facial hair

Exclusion Criteria:

* Any systemic antibiotics used to treat acne (injected or oral)within 6 months of starting study. Any 14-day or shorter course of systemic antibiotics (injected or oral) used to treat conditions other than acne within 1 month of starting study
* Any topical antibiotic or benzoyl peroxide within 1 month of starting study or any subject unwilling to refrain from washout of topical antibacterial or benzoyl peroxide ingredient.
* Any oral probiotic or prebiotic supplementation within past 1 month
* Subjects must have no history of malignancy or cancer or diagnosis of gastrointestinal inflammatory diseases, no history or diagnosis of epilepsy, no history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis)
* Has a condition or is on medication the investigator and/or designee believe could jeopardize the safety of the subject, interfere with the evaluation, or confound the interpretation of the study results
* Women who have been pregnant in the last three months, are pregnant, preparing to be pregnant or lactating, or post-menopausal.
* Is participating in a concurrent clinical research study or has participated in acne or other facial study at this or any other facility in the past 4 weeks
* Those with BMI higher than 35kg/m²
* Those that have undergone a change in hormonally based therapies, such as but not limited to oral contraceptive pills or progesterone based pills within the last two months. Progesterone releasing IUDs and spironolactone are considered hormone-based therapy.
* Commencement of a new diet (such as the ketogenic diet)or supplements within the 1 month prior to initiating participation, at the discretion of the investigator.
* Use of medications that alter blood lipids, such as statins and anti-hyperlipidemic medications
* Is participating in or has participated in acne or other facial study at this or any other facility in the past 4 weeks. Participation in survey-based studies are approved at the discretion of the investigator.
* Has a skin disease on face, other than acne, that will interfere with image collection and assessment in the opinion of the investigator
* Refusal to shave or remove facial hair that may interfere with image collection and assessment.
* Severe acne or nodulocystic acne, at the discretion of the investigator
* Use of isotretinoin within the 6 months prior to starting in study.
* Persons unwilling to avoid the following during the 4 weeks prior and during the duration of the study: self-tanning, spa tanning, or artificial tanning.
* Known allergy or irritation to the supplement or facial products utilized in the study
* Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco
* Prisoners
* Adults unable to consent

Primary outcomes:
measure: Microbiota Diversity
timeFrame: 12 weeks
measure: Short chain fatty acids
timeFrame: 12 weeks
measure: Blood acetate levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Gut microbiome changes
timeFrame: 4 weeks and 8 weeks
measure: Change in skin microbiome
timeFrame: 12 weeks
measure: Safety assessments for GI distress
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Change in sebum excretion rate
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Change in skin hydration
timeFrame: 4,8 and 12 weeks
measure: Change in skin pH
timeFrame: 4,8, and 12 weeks
measure: Facial redness - Image based
timeFrame: 4,8,12 weeks
measure: Facial skin tone - Image based
timeFrame: 4,8,12 weeks
measure: Subjective assessment of the skin
timeFrame: 4,8,12 weeks
measure: Safety assessment of acne
timeFrame: 4, 8, 12 weeks
measure: Gut Microbiome Changes
timeFrame: 4, 8, 12 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
References: