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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05941065
Other study ID # BB_SKIN_BALANCE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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