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

NCT05941065 | Unknown

• 1 other identifier: BB_SKIN_BALANCE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Microboime; Acne

Keywords

Skin; Microbiome

Outcome Measures

Primary Outcomes (1)

• C. acnes relative abundance

  Shift in the C. acnes relative abundance based on skin microbiome swab collection and sequencing

  6 weeks

Secondary Outcomes (4)

• Functional gene based predictive analysis of skin inflammation related genes

  6 weeks

• Sebum excretion rate

  6 weeks

• Tolerability Assessment Questionnaire

  6 weeks

• Total lesion count

  6 weeks

Study Arms (1)

Balancing gel cream

EXPERIMENTAL

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

Interventions

Balancing gel cream OTHER

Skin balancing gel cream will be applied onto clean skin morning and night

Balancing gel cream

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integrative Skin Science and Research: lead
• Burt's Bees Inc.: collaborator

Study Sites (1)

Integrative Skin and Research

Sacramento, California, 95815, United States

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Raja Sivamani, MD MS AP

  Integrative Skin Science and Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nhi Nguyen

CONTACT

916-750-2463; research@integrativeskinresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 12, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)