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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acne; Skin Microboime
• Intervention / Treatment: Other: Balancing gel cream

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nhi Nguyen; Phone Number: 916-750-2463; Email: research@integrativeskinresearch.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Recruiting
      • Integrative Skin and Research
      • Principal Investigator: Raja Sivamani, MD MS AP
      • Contact: Raja Sivamani, MD, MS, AP; Phone Number: 916-750-2463; Email: research@integrativeskinresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balancing gel cream; 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.	Other: Balancing gel cream; Skin balancing gel cream will be applied onto clean skin morning and night

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C. acnes relative abundance	Shift in the C. acnes relative abundance based on skin microbiome swab collection and sequencing	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Sebum excretion rate	Measure of skin sebum via sebumeter	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	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.	6 weeks

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Burt's Bees Inc.
• Investigators: Principal Investigator: Raja Sivamani, MD MS AP, Integrative Skin Science and Research

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Microbiome; Skin
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: BB_SKIN_BALANCE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No