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

Integrative Skin Science and Research

Status: Enrolling

Conditions: Skin Microboime; Acne

Treatments: Other: Balancing gel cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT05941065

BB_SKIN_BALANCE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Balancing gel cream

Experimental group

Description:

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.

Treatment:

Other: Balancing gel cream