Acne VulgarisNCT04596748
Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris
A study testing Probiotic in people with Acne Vulgaris, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
The purpose of this study is to determine how probiotics affect sebum production and gut health in those with acne vulgaris. Read more about this study
- Who is it for?
- Ages 13 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2020to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Integrative Skin Science and Research
Sacramento, California, 95815
Raja K Sivamani, MD, 916-524-1216, raja.sivamani@integrativeskinresearch.com
About this study
Official title: Prospective Randomized Double-Blind Placebo-Controlled Study of Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris
The purpose of this study is to determine how probiotics affect sebum production and gut health in those with acne vulgaris.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Probiotic, Placebo
- Keywords
- acne vulgaris, skin, dermatology, acne, microbiome, probiotics
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Bacillus Subtilis, Bacillus Clausii, Bacillus Coagulans, Bacillus Indicus HU36, MCC 102
PlaceboDietary supplement
Placebo caps
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will be taking a placebo supplement that they will be taking by mouth once per day. Receives: Dietary Supplement: Placebo |
| Probiotic | Experimental | Participants will be taking a probiotic supplement that they will be taking by mouth once per day. Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota Diversity
Evaluation of alpha diversity
Measured: 12 weeks
Short chain fatty acids
Blood plasma
Measured: 12 weeks
Blood acetate levels
Blood plasma
Measured: 12 weeks
Secondary outcomes (11)
Gut microbiome changes
Evaluation of alpha diversity
Measured: 4 weeks and 8 weeks
Change in skin microbiome
Relative abundance cutibacterium genera
Measured: 12 weeks
Safety assessments for GI distress
Self assessment using Digestive Questionnaire
Measured: 4 weeks, 8 weeks, 12 weeks
Change in sebum excretion rate
Sebumeter: 0-150 micrograms/cm^2
Measured: 4 weeks, 8 weeks, 12 weeks
Change in skin hydration
Moisturemeter: 0-150
Measured: 4,8 and 12 weeks
Change in skin pH
Use of pH meter
Measured: 4,8, and 12 weeks
Facial redness - Image based
BTBP Clarity Mini 3D camera
Measured: 4,8,12 weeks
Facial skin tone - Image based
BTBP Clarity Mini 3D camera
Measured: 4,8,12 weeks
Subjective assessment of the skin
Self-assessment through Dermatology Quality of Life questionnaire
Measured: 4,8,12 weeks
Safety assessment of acne
Evaluation of acne to assess for flares
Measured: 4, 8, 12 weeks
Gut Microbiome Changes
Relative abundance of Akkermansia muciniphila
Measured: 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start11 May 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Microbiome labs
- Responsible party
- Principal investigator, Raja Sivamani, Integrative Skin Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596748
- Sponsor's protocol ID
- ISSR-Prob-GutSkin
- Status last verified
- Nov 2020
- First submitted
- 9 Oct 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Double-Blind Placebo-Controlled Study of Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris
- ClinicalTrials.gov ID
- NCT04596748
- Acronym / sponsor ID
- ISSR-Prob-GutSkin
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris, skin, dermatology, acne, microbiome, probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Microbiome labs
- Study start
- 11 May 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will be taking a placebo supplement that they will be taking by mouth once per day. |
| Probiotic | Experimental | Dietary Supplement: ProbioticParticipants will be taking a probiotic supplement that they will be taking by mouth once per day. |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticBacillus Subtilis, Bacillus Clausii, Bacillus Coagulans, Bacillus Indicus HU36, MCC 102 | Dietary supplement | Probiotic |
| PlaceboPlacebo caps | Dietary supplement | Placebo |
Primary outcome
Microbiota Diversity
Time frame: 12 weeks
Evaluation of alpha diversity
Short chain fatty acids
Time frame: 12 weeks
Blood plasma
Blood acetate levels
Time frame: 12 weeks
Blood plasma
11 secondary outcomes
Gut microbiome changes
Time frame: 4 weeks and 8 weeks
Change in skin microbiome
Time frame: 12 weeks
Safety assessments for GI distress
Time frame: 4 weeks, 8 weeks, 12 weeks
Change in sebum excretion rate
Time frame: 4 weeks, 8 weeks, 12 weeks
Change in skin hydration
Time frame: 4,8 and 12 weeks
Change in skin pH
Time frame: 4,8, and 12 weeks
Facial redness - Image based
Time frame: 4,8,12 weeks
Facial skin tone - Image based
Time frame: 4,8,12 weeks
Subjective assessment of the skin
Time frame: 4,8,12 weeks
Safety assessment of acne
Time frame: 4, 8, 12 weeks
Gut Microbiome Changes
Time frame: 4, 8, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Acne Vulgaris, run by Integrative Skin Science and Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raja K Sivamani, MD (916-524-1216, raja.sivamani@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota Diversity (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.