Recruiting

Skin Balancing Gel Cream

Sponsor:

Integrative Skin Science and Research

Code:

NCT05941065

Conditions

Skin Microboime

Acne

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Balancing gel cream

Study Details

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

Study ID

NCT05941065

Start date

Sep 1, 2023

Status verified date

Oct, 2023

Completion date

Apr, 2024

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Balancing gel cream

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

Primary outcome measure

  • C. acnes relative abundance [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Nhi Nguyen

916-750-2463research@integrativeskinresearch.com

Locations

Integrative Skin and Research

Recruiting

Sacramento, California, United States, 95815

Contacts

Raja Sivamani, MD, MS, AP

916-750-2463research@integrativeskinresearch.com

Principal Investigator:

Raja Sivamani, MD MS AP

More Information

Sponsor

Integrative Skin Science and Research

Last update posted

Oct 10, 2023

Last verified

Oct, 2023

Keywords

  • Skin
  • Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Integrative Skin Science and Research on 2023-10-10.