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Antibacterial

Skin Cleanser for Eczema

Phase 4

Waitlist Available

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

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

Must have

Must not have

History of HIV, hepatitis B, hepatitis C, tuberculosis malignancy

Severe ongoing medical illnesses e.g. cardiovascular, renal disease, autoimmune disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to test if removing S. aureus bacteria from the skin of patients with atopic dermatitis can improve the skin condition and change how the skin cells and immune cells behave to reduce the

Who is the study for?

This trial is for males and females aged 6 years or older who have been diagnosed with atopic dermatitis, a type of eczema. Participants must have a SCORAD (a measure of eczema severity) greater than 40 to join.

What is being tested?

The study is testing whether using Skin Cleanser Combination No.1 can reduce the severity of atopic dermatitis by removing S. aureus bacteria from the skin and improving skin cell function.

What are the potential side effects?

Potential side effects are not specified in the provided information but may include skin irritation or dryness due to the cleanser, allergic reactions, or changes in skin flora.

Eligibility Criteria

Exclusion Criteria

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

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I have a history of HIV, hepatitis B, hepatitis C, or tuberculosis.

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I do not have severe ongoing illnesses like heart or kidney disease.

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I use more than 500 μg of inhaled corticosteroids daily for my asthma.

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I may have an immune deficiency or it runs in my family.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks

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

Severity Scoring of Atopic Dermatitis Index

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Skin Cleansing RegimenExperimental Treatment1 Intervention

1. Mupirocin 2% nasal ointment to the anterior nares to be applied twice daily 2. Chlorhexidine 4% topical soap (Hibiclens) to be used every other day in the shower or bath from the neck down and then completely rinsed. 3. Sulfamethoxazole/trimethoprim (Bactrim): one double strength (DS) tablet (800 mg/160 mg) twice per day for adolescents and adults

0 / 4Eligibility criteria met