Acne VulgarisNCT05271487
A Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome
A study testing Multi-Step Botanical Skin Care Regimen 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 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. Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Multi-Step Botanical Skin Care Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 1 Mar 2023
- 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 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects 15 years of age until 45 years of age.
- The presence of mild to moderate acne based on investigator global assessment.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Skin Science and Research
Sacramento, California, 95819
Jessica Maloh, 916-750-2463, jessica@integrativeskinresearch.com
Raja Sivamani, MD MS AP
About this study
Official title: The Effects of a Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome
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.
- Conditions
- Acne Vulgaris
- Being tested
- Multi-Step Botanical Skin Care Regimen
- Keywords
- botanical, microbiome, skin care
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Step Botanical Skin Care RegimenOther
The intervention includes 7 different topical products:
- Cleanser
- Toner
- Oil Control Cream
- Exfoliating Facial Scrub
- Clay Mask
- Acne Spot Treatment
- Body Scrub
| Study group | Role | What they receive |
|---|---|---|
| Multi-Step Botanical Skin Care Regimen | Experimental | The patient will be provided with and instructed to use a cleanser, toner, oil control cream, exfoliating facial scrub, clay mask, acne spot treatment, and body scrub for the duration of the study. Receives: Other: Multi-Step Botanical Skin Care Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total lesion count
Number of of inflammatory lesions, and open and closed comedones
Measured: 8 weeks
Secondary outcomes (18)
Inflammatory lesion count
Number of inflammatory lesions
Measured: 4 weeks
Inflammatory lesion count
Number of inflammatory lesions
Measured: 8 weeks
Non-inflammatory lesion count
Number of open and closed comedones
Measured: 4 weeks
Non-inflammatory lesion count
Number of open and closed comedones
Measured: 8 weeks
Investigator global assessment (IGA) of acne
Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne
Measured: 4 weeks
Investigator global assessment (IGA) of acne
Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne
Measured: 8 weeks
Sebum excretion
Measure of skin sebum via sebumeter
Measured: 4 weeks
Sebum excretion
Measure of skin sebum via sebumeter
Measured: 8 weeks
Gut microbiome assessment
Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample
Measured: 4 weeks
Gut microbiome assessment
Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample
Measured: 8 weeks
Skin microbiome diversity
Shift in Shannon diversity of the skin microbiome
Measured: 4 weeks
Skin microbiome diversity
Shift in Shannon diversity of the skin microbiome
Measured: 8 weeks
Positive and Negative Affect Schedule (PANAS-SF)
Survey assessing positive and negative mood states. Scores range from 10 to 50 with higher scores representing positive affect
Measured: 4 weeks
Positive and Negative Affect Schedule (PANAS-SF)
Survey assessing positive and negative mood states. Scores range from 10 to 50 with higher scores representing positive affect
Measured: 8 weeks
Diurnal Cortisol Slope
4 salivary cortisol collections to assess diurnal slope
Measured: 4 weeks
Diurnal Cortisol Slope
4 salivary cortisol collections to assess diurnal slope
Measured: 8 weeks
Salivary Sex Hormone Levels
1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS
Measured: 4 weeks
Salivary Sex Hormone Levels
1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start7 Mar 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Mar 2023 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Codex Beauty Corporation
- Responsible party
- Principal investigator, Raja Sivamani, MD MS AP, Integrative Skin Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271487
- Sponsor's protocol ID
- CB_Acne_01
- Status last verified
- Feb 2022
- First submitted
- 25 Feb 2022
- Last updated
- 9 Mar 2022
- 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 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome
- ClinicalTrials.gov ID
- NCT05271487
- Acronym / sponsor ID
- CB_Acne_01
- Conditions
- Acne Vulgaris
- Keywords
- botanical, microbiome, skin care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Codex Beauty Corporation
- Study start
- 7 Mar 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 9 Mar 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-Step Botanical Skin Care Regimen | Experimental | Other: Multi-Step Botanical Skin Care RegimenThe patient will be provided with and instructed to use a cleanser, toner, oil control cream, exfoliating facial scrub, clay mask, acne spot treatment, and body scrub for the duration of the study. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Subjects 15 years of age until 45 years of age.
- The presence of mild to moderate acne based on investigator global assessment.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Multi-Step Botanical Skin Care RegimenThe intervention includes 7 different topical products: 1. Cleanser 2. Toner 3. Oil Control Cream 4. Exfoliating Facial Scrub 5. Clay Mask 6. Acne Spot Treatment 7. Body Scrub | Other | Multi-Step Botanical Skin Care Regimen |
Primary outcome
Total lesion count
Time frame: 8 weeks
Number of of inflammatory lesions, and open and closed comedones
18 secondary outcomes
Inflammatory lesion count
Time frame: 4 weeks
Inflammatory lesion count
Time frame: 8 weeks
Non-inflammatory lesion count
Time frame: 4 weeks
Non-inflammatory lesion count
Time frame: 8 weeks
Investigator global assessment (IGA) of acne
Time frame: 4 weeks
Investigator global assessment (IGA) of acne
Time frame: 8 weeks
Sebum excretion
Time frame: 4 weeks
Sebum excretion
Time frame: 8 weeks
Gut microbiome assessment
Time frame: 4 weeks
Gut microbiome assessment
Time frame: 8 weeks
Skin microbiome diversity
Time frame: 4 weeks
Skin microbiome diversity
Time frame: 8 weeks
Positive and Negative Affect Schedule (PANAS-SF)
Time frame: 4 weeks
Positive and Negative Affect Schedule (PANAS-SF)
Time frame: 8 weeks
Diurnal Cortisol Slope
Time frame: 4 weeks
Diurnal Cortisol Slope
Time frame: 8 weeks
Salivary Sex Hormone Levels
Time frame: 4 weeks
Salivary Sex Hormone Levels
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- 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 Multi-Step Botanical Skin Care Regimen 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 2 inclusion and 11 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 9 Mar 2022. 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. 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 Jessica Maloh (9167502463, jessica@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total lesion count (time frame: 8 weeks). 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 9 Mar 2022.