Skin MicroboimeNCT05941065
Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
A study testing Balancing gel cream in people with Skin Microboime and Acne, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety of the skin balancing gel cream and examine the effects it has on the skin microbiome of individuals with non-cystic acne prone skin. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Microboime, Acne
- What is being tested?
- Balancing gel cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to Apr 2024
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females between the ages of 18 years of age until 35 years of age
- Males must be willing to shave facial hair
- The presence of mild to moderate non-cystic acne based on investigator global assessment
Who cannot join
- Individuals who are pregnant or breastfeeding.
- Prisoners.
- Adults unable to consent.
- The presence of severe acne or cysts as noted by the investigator.
- Those who are unwilling to discontinue topical antibiotics, topical salicylic acid containing products and topical benzoyl peroxide containing products for two weeks to meet the washout criteria prior to enrolling.
- Those who are unwilling to discontinue all facial topical products except the cleanser and the product provided in the study.
Show all 9Show fewer
- Individuals who have been on an oral antibiotic for acne within the previous 1 month.
- Individuals who have changed any of their hormonal based contraception within 3. 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, 1 recruiting
- Recruiting
Integrative Skin and Research
Sacramento, California, 95815
Raja Sivamani, MD, MS, AP, 916-750-2463, research@integrativeskinresearch.com
Raja Sivamani, MD MS AP
About this study
Official title: Open-label, Prospective Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
The purpose of this study is to assess the safety of the skin balancing gel cream and examine the effects it has on the skin microbiome of individuals with non-cystic acne prone skin.
Read the detailed description
Acne, a chronic inflammatory condition, is estimated to affect greater than 85% of the population at some point. It is considered a common skin condition characterized by pimples and occurs when follicles are clogged leading to the formation of acne lesions. In this study, we want to evaluate the impact the skin balancing gel cream has on the skin microbiome on individuals who have mild to moderate non-cystic acne. We will be assessing the changes it has on specific microbiota (Cutibacterium acnes for example) and whether it is tolerated well on acne prone skin.
- Conditions
- Skin Microboime, Acne
- Being tested
- Balancing gel cream
- Keywords
- Skin, Microbiome
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balancing gel creamOther
Skin balancing gel cream will be applied onto clean skin morning and night
| Study group | Role | What they receive |
|---|---|---|
| Balancing gel cream | Experimental | Product will be used twice daily in the morning and in the evening for 6 weeks. 1-2 pumps (dime size) of product will be applied on the face.
In addition to the study product, a Cetaphil cleanser will be used as well. Cleanser will be applied twice daily in the morning and in the evening for 6 weeks. Cleanser will be used on wet face and gently pat dry. Receives: Other: Balancing gel cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
C. acnes relative abundance
Shift in the C. acnes relative abundance based on skin microbiome swab collection and sequencing
Measured: 6 weeks
Secondary outcomes (4)
Functional gene based predictive analysis of skin inflammation related genes
Functional gene analysis for skin inflammation related genes from whole genome sequencing of facial skin microbiome
Measured: 6 weeks
Sebum excretion rate
Measure of skin sebum via sebumeter
Measured: 6 weeks
Tolerability Assessment Questionnaire
A 6 question survey based on the self-assessment about the tolerability of the topical skin product such as itching, burning, and stinging. The scale ranges from 0-3 with 0 being the best outcome possible and with 3 being the worst.
"0" as none, "1" as mild, "2" as moderate, or "3" as severe.
Measured: 6 weeks
Total lesion count
Safety endpoint to count inflammatory and non-inflammatory lesions to ensure that there is not a flare in the acne
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Sep 2023
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin MicroboimeStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Burt's Bees Inc.
- Responsible party
- Sponsor
- Investigators
- Raja Sivamani, MD MS AP, Principal investigator, Integrative Skin Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941065
- Sponsor's protocol ID
- BB_SKIN_BALANCE
- Status last verified
- Oct 2023
- First submitted
- 4 Jul 2023
- Last updated
- 10 Oct 2023
- 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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Prospective Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
- ClinicalTrials.gov ID
- NCT05941065
- Acronym / sponsor ID
- BB_SKIN_BALANCE
- Conditions
- Skin Microboime, Acne
- Keywords
- Skin, Microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Burt's Bees Inc.
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 12 Jul 2023 (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 assess the safety of the skin balancing gel cream and examine the effects it has on the skin microbiome of individuals with non-cystic acne prone skin.
Detailed description
Acne, a chronic inflammatory condition, is estimated to affect greater than 85% of the population at some point. It is considered a common skin condition characterized by pimples and occurs when follicles are clogged leading to the formation of acne lesions. In this study, we want to evaluate the impact the skin balancing gel cream has on the skin microbiome on individuals who have mild to moderate non-cystic acne. We will be assessing the changes it has on specific microbiota (Cutibacterium acnes for example) and whether it is tolerated well on acne prone skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balancing gel cream | Experimental | Other: Balancing gel creamProduct will be used twice daily in the morning and in the evening for 6 weeks. 1-2 pumps (dime size) of product will be applied on the face. In addition to the study product, a Cetaphil cleanser will be used as well. Cleanser will be applied twice daily in the morning and in the evening for 6 weeks. Cleanser will be used on wet face and gently pat dry. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females between the ages of 18 years of age until 35 years of age
- Males must be willing to shave facial hair
- The presence of mild to moderate non-cystic acne based on investigator global assessment
Key exclusion criteria (9 listed)
- Individuals who are pregnant or breastfeeding.
- Prisoners.
- Adults unable to consent.
- The presence of severe acne or cysts as noted by the investigator.
- Those who are unwilling to discontinue topical antibiotics, topical salicylic acid containing products and topical benzoyl peroxide containing products for two weeks to meet the washout criteria prior to enrolling.
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 |
|---|---|---|
| Balancing gel creamSkin balancing gel cream will be applied onto clean skin morning and night | Other | Balancing gel cream |
Primary outcome
C. acnes relative abundance
Time frame: 6 weeks
Shift in the C. acnes relative abundance based on skin microbiome swab collection and sequencing
4 secondary outcomes
Functional gene based predictive analysis of skin inflammation related genes
Time frame: 6 weeks
Sebum excretion rate
Time frame: 6 weeks
Tolerability Assessment Questionnaire
Time frame: 6 weeks
Total lesion count
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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.
Raja Sivamani, MD MS AP principal investigator
Integrative Skin Science and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balancing gel cream in people with Skin Microboime and Acne, 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 3 inclusion and 9 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 10 Oct 2023. 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 Nhi Nguyen (916-750-2463, research@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C. acnes relative abundance (time frame: 6 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 10 Oct 2023.