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Balancing Gel Cream for Acne

N/A

Recruiting

Led By Raja Sivamani, MD MS AP

Research Sponsored by Integrative Skin Science and Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females between the ages of 18 years of age until 35 years of age

Be between 18 and 65 years old

Must not have

Those who are unwilling to discontinue all facial topical products except the cleanser and the product provided in the study

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how a skin cream affects acne-prone skin and the bacteria living on it.

Who is the study for?

This trial is for men and women aged 18-35 with mild to moderate non-cystic acne. Participants must not be pregnant, breastfeeding, or unable to consent. They should agree to shave facial hair if needed, stop certain acne treatments before starting the study, and avoid using any facial products except those provided in the study.

What is being tested?

The trial is testing a skin balancing gel cream's safety and its impact on the skin microbiome of people with acne-prone skin. The goal is to see if this cream can help manage acne by influencing the natural bacteria on the skin.

What are the potential side effects?

While specific side effects are not listed, typical reactions may include skin irritation, redness, dryness or peeling where the product is applied. Any unexpected effects related to applying this topical treatment will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am willing to only use the cleanser and study product on my face.

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I am willing to stop using certain skin treatments for two weeks before joining.

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I currently smoke or have smoked a lot in the past.

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I am unable to give consent for medical procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

C. acnes relative abundance

Secondary study objectives

Functional gene based predictive analysis of skin inflammation related genes

Sebum excretion rate

Tolerability Assessment Questionnaire

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Balancing gel creamExperimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met