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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 35 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
C. acnes relative abundance
Secondary outcome measures
Functional gene based predictive analysis of skin inflammation related genes
Sebum excretion rate
Tolerability Assessment Questionnaire
+1 moreTrial 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.
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Who is running the clinical trial?
Burt's Bees Inc.Industry Sponsor
2 Previous Clinical Trials
100 Total Patients Enrolled
Integrative Skin Science and ResearchLead Sponsor
31 Previous Clinical Trials
2,702 Total Patients Enrolled
2 Trials studying Acne
1,022 Patients Enrolled for Acne
Raja Sivamani, MD MS APPrincipal InvestigatorIntegrative Skin Science and Research
4 Previous Clinical Trials
166 Total Patients Enrolled
1 Trials studying Acne
22 Patients Enrolled for Acne
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to only use the cleanser and study product on my face.I have severe acne or cysts as confirmed by a doctor.I am willing to stop using certain skin treatments for two weeks before joining.I am between 18 and 35 years old.I currently smoke or have smoked a lot in the past.I have mild to moderate acne, not cystic, confirmed by a doctor.I am unable to give consent for medical procedures.I have taken an oral antibiotic for acne in the last month.You have switched your hormonal birth control within the last 3 months before joining the study.I am willing to shave my facial hair.
Research Study Groups:
This trial has the following groups:- Group 1: Balancing gel cream
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are minors eligible for participating in this medical research?
"Eligible participants must be between the ages of 18 and 35."
Answered by AI
Can I qualify to join this research project?
"Eligibility for this trial necessitates having a diagnosis of acne and being between 18 and 35 years old. Approximately 30 patients are to be enrolled in the experiment."
Answered by AI
Are there currently openings for participants in this experiment?
"As indicated by clinicaltrials.gov, this research project is no longer recruiting participants. Initially posted on July 15th 2023 and last edited on the 4th of July 2023, 43 other trials are welcoming patients at present time."
Answered by AI
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