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

Integrative Skin Science and Research30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Microboime Acne

Interventions

Balancing gel creamOTHER

Skin balancing gel cream will be applied onto clean skin morning and night

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Integrative Skin and Research

Sacramento, California, United States

RECRUITING

Outcomes

Primary Outcomes

C. acnes relative abundance

Shift in the C. acnes relative abundance based on skin microbiome swab collection and sequencing

Time frame: 6 weeks

Secondary Outcomes

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

Time frame: 6 weeks

Sebum excretion rate

Measure of skin sebum via sebumeter

Time frame: 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.

Time frame: 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

Time frame: 6 weeks

Central Contacts

Nhi Nguyen

CONTACT

916-750-2463 research@integrativeskinresearch.com

Data from ClinicalTrials.gov

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