Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
- Conditions
- AcneSkin Microboime
- Interventions
- Other: Balancing gel cream
- Registration Number
- NCT05941065
- Lead Sponsor
- Integrative Skin Science and Research
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Balancing gel cream Balancing gel cream 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.
- Primary Outcome Measures
Name Time Method C. acnes relative abundance 6 weeks Shift in the C. acnes relative abundance based on skin microbiome swab collection and sequencing
- Secondary Outcome Measures
Name Time Method Functional gene based predictive analysis of skin inflammation related genes 6 weeks Functional gene analysis for skin inflammation related genes from whole genome sequencing of facial skin microbiome
Sebum excretion rate 6 weeks Measure of skin sebum via sebumeter
Tolerability Assessment Questionnaire 6 weeks 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.Total lesion count 6 weeks Safety endpoint to count inflammatory and non-inflammatory lesions to ensure that there is not a flare in the acne
Trial Locations
- Locations (1)
Integrative Skin and Research
🇺🇸Sacramento, California, United States