Acneiform Eruptions, Acne Vulgaris, Sebaceous Gland Diseases, Skin Diseases
Conditions
Keywords
microbiome, probiotics, dietary supplementation
Brief summary
The purpose of this study is to evaluates how probiotics and dietary supplementation with an herbal powder can shift the gut microbiome in those with non-cystic acne vulgaris.
Detailed description
The investigators hope to evaluate the effects of oral supplements in changing intestinal health and the gut bacteria in patients with non-cystic acne vulgaris. Acne is a chronic inflammatory condition that is estimated to affect greater than 85% of the population at some point. While antibiotics are typically used for systemic therapy, it can increase the risk for drug-resistant bacteria and shift the gut microbiome in a negative way. On the other hand, probiotics and dietary supplementation have been shown to support the gut microbiome. In this study, participants will be randomized to either receiving a probiotic or powder supplement. This means that participants will have an equal chance of receiving either product as half of the participants will be randomized to receive only oral probiotic, and the other half will receive oral supplement powder.
Interventions
OTHERProbiotic
Oral probiotic
DIETARY_SUPPLEMENTOral herbal powder supplement
oral herbal powder
Sponsors
Codex Labs
Integrative Skin Science and Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects 12 years of age until 45 years of age * The presence of mild to moderate acne based on investigator global assessment. * Presence of at least 10 inflammatory lesions and at least 5 non-inflammatory lesions
Exclusion criteria
* The presence of severe acne as noted by the investigator global assessment. * Those who are unwilling to discontinue oral probiotic-based supplementation, or supplement ingredients found in the study's oral product 1 month prior to enrollment. * Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide for 2 weeks prior to enrollment * Those who are unwilling to keep their facial regimen the same throughout the study * Individuals who have been on an oral antibiotic for acne within the previous one month. * Individuals who are pregnant or breastfeeding. * Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study. * Individuals on oral contraceptive pills or progesterone or estrogen containing therapies * Use of isotretinoin within the three months prior to enrollment. * Individuals on finasteride or dutasteride * Current tobacco smoker or a tobacco smoking history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome composition of short chain fatty acid producing bacteria | 8 weeks | Change on the relative abundance of Akkermansia mucinaphila and Facelibacterium pruasntizii |
| Stool acetate levels | 8 weeks | Assess the short chain fatty acid stool acetate levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in salivary progesterone levels | 4 weeks | Progesterone and 17-OH progesterone levels |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total lesion count | 4 weeks | Safety endpoint to count inflammatory and non-inflammatory lesions |
Countries
United States
Outcome results
None listed