Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin

Study Overview
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Brief Summary
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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
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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.

Official Title
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Open-label, Prospective Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin

Conditions
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Skin Microboime, Acne

Intervention / Treatment
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* Other: Balancing gel cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balancing gel cream<br>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. | Other: Balancing gel cream<br>* Skin balancing gel cream will be applied onto clean skin morning and night<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C. acnes relative abundance | Shift in the C. acnes relative abundance based on skin microbiome swab collection and sequencing | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 weeks | 
| Sebum excretion rate | Measure of skin sebum via sebumeter | 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. | 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 | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin, Microbiome