Assessing a gel cream's safety and its effects on skin microbiome in acne-prone individuals
Open-label, Prospective Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
This study tests a new gel cream to see if it’s safe and how it affects the skin's natural bacteria in people with mild to moderate acne.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Integrative Skin Science and Research Industry-sponsored |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT05941065 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of a skin balancing gel cream and its influence on the skin microbiome in individuals with mild to moderate non-cystic acne. Participants will apply the gel cream, and researchers will monitor changes in specific microbiota, such as Cutibacterium acnes, to determine the product's effects on acne-prone skin. The study aims to understand how the gel cream interacts with the skin's natural microbiome and whether it is well-tolerated by users.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 35 with mild to moderate non-cystic acne.
Not a fit: Patients with severe acne or cystic lesions, as well as those currently using certain topical treatments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option that effectively manages acne while promoting a healthy skin microbiome.
How similar studies have performed: While the approach of examining the skin microbiome in relation to acne treatment is gaining interest, this specific intervention is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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.
Where this trial is running
Sacramento, California
- Integrative Skin and Research — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Raja Sivamani, MD MS AP — Integrative Skin Science and Research
- Study coordinator: Nhi Nguyen
- Email: research@integrativeskinresearch.com
- Phone: 916-750-2463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.