Acne Vulgaris Clinical Trial
Official title:
The Effects of Oral Probiotics and Herbal Supplementation on the Gut Microbiome and Sebum Excretion Rate in Non-Cystic Acne
Verified date | May 2024 |
Source | Integrative Skin Science and Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 36 |
Est. completion date | July 31, 2024 |
Est. primary completion date | February 12, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Integrative Skin Science and Research | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Integrative Skin Science and Research | Codex Labs |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Total lesion count | Safety endpoint to count inflammatory and non-inflammatory lesions | 4 weeks | |
Other | Total lesion count | Safety endpoint to count inflammatory and non-inflammatory lesions | 8 weeks | |
Primary | Gut microbiome diversity | Change on the Shannon diversity of the gut microbiome | 4 weeks | |
Primary | Sebum excretion rate | Measure of skin sebum via sebumeter | 4 weeks | |
Secondary | Diurnal Cortisol Slope | 4 point salivary cortisol collections to assess diurnal slope | 4 weeks | |
Secondary | Diurnal Cortisol Slope | 4 point salivary cortisol collections to assess diurnal slope | 8 weeks | |
Secondary | Salivary Dihydrotestosterone | Salivary collection to assess dihydrotestosterone | 4 weeks | |
Secondary | Salivary Dihydrotestosterone | Salivary collection to assess dihydrotestosterone | 8 weeks | |
Secondary | Gut microbiome diversity | Change on the Shannon diversity of the gut microbiome | 8 weeks | |
Secondary | Sebum excretion rate | Measure of skin sebum via sebumeter | 8 weeks |
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