Clinical trial NCT05941065: Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
Official title: Open-label, Prospective Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Microboime
Acne
Keywords: Skin
Microbiome
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Burt's Bees Inc.
First posted: 2023-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: C. acnes relative abundance
timeFrame: 6 weeks
Secondary outcomes:
measure: Functional gene based predictive analysis of skin inflammation related genes
timeFrame: 6 weeks
measure: Sebum excretion rate
timeFrame: 6 weeks
measure: Tolerability Assessment Questionnaire
timeFrame: 6 weeks
measure: Total lesion count
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin and Research
state: California
Study officials:
affiliation: Integrative Skin Science and Research
name: Raja Sivamani, MD MS AP
role: PRINCIPAL_INVESTIGATOR
References: