Back to resultsStudy of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
Primary Purpose
Skin Microboime, Acne
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Balancing gel cream
Sponsored by
About this trial
This is an interventional treatment trial for Skin Microboime focused on measuring Skin, Microbiome
Eligibility Criteria
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.
Sites / Locations
- Integrative Skin and ResearchRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Balancing gel cream
Arm 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.
Outcomes
Primary Outcome Measures
C. acnes relative abundance
Shift in the C. acnes relative abundance based on skin microbiome swab collection and sequencing
Secondary Outcome Measures
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
Sebum excretion rate
Measure of skin sebum via sebumeter
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.
Total lesion count
Safety endpoint to count inflammatory and non-inflammatory lesions to ensure that there is not a flare in the acne
Full Information
NCT ID
NCT05941065
First Posted
July 4, 2023
Last Updated
October 6, 2023
Sponsor
Integrative Skin Science and Research
Collaborators
Burt's Bees Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05941065
Brief Title
Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
Official Title
Open-label, Prospective Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integrative Skin Science and Research
Collaborators
Burt's Bees Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Microboime, Acne
Keywords
Skin, Microbiome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Balancing gel cream
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Balancing gel cream
Intervention Description
Skin balancing gel cream will be applied onto clean skin morning and night
Primary Outcome Measure Information:
Title
C. acnes relative abundance
Description
Shift in the C. acnes relative abundance based on skin microbiome swab collection and sequencing
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Functional gene based predictive analysis of skin inflammation related genes
Description
Functional gene analysis for skin inflammation related genes from whole genome sequencing of facial skin microbiome
Time Frame
6 weeks
Title
Sebum excretion rate
Description
Measure of skin sebum via sebumeter
Time Frame
6 weeks
Title
Tolerability Assessment Questionnaire
Description
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
Title
Total lesion count
Description
Safety endpoint to count inflammatory and non-inflammatory lesions to ensure that there is not a flare in the acne
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nhi Nguyen
Phone
916-750-2463
Email
research@integrativeskinresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja Sivamani, MD MS AP
Organizational Affiliation
Integrative Skin Science and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrative Skin and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raja Sivamani, MD, MS, AP
Phone
916-750-2463
Email
research@integrativeskinresearch.com
First Name & Middle Initial & Last Name & Degree
Raja Sivamani, MD MS AP
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
We'll reach out to this number within 24 hrs