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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05941065
• Other study ID #: BB_SKIN_BALANCE
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: Integrative Skin Science and Research
• Contact: Nhi Nguyen
• Phone: 916-750-2463
• Email: research[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Other:
• Balancing gel cream
Skin balancing gel cream will be applied onto clean skin morning and night

Locations

Country	Name	City	State
United States	Integrative Skin and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Burt's Bees Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C. acnes relative abundance	Shift in the C. acnes relative abundance based on skin microbiome swab collection and sequencing	6 weeks
Secondary	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
Secondary	Sebum excretion rate	Measure of skin sebum via sebumeter	6 weeks
Secondary	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
Secondary	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