Skin Cleanser for Eczema
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new skin cleanser, Skin Cleanser Combination No.1, to determine its effectiveness for people with eczema, a condition that causes dry, itchy skin. Researchers believe reducing certain bacteria on the skin might lessen eczema symptoms by improving skin cell function and immune response. Participants will follow a special cleansing regimen that includes a nasal ointment, a topical soap, and an oral medication. This trial may suit individuals with severe eczema who haven't recently used treatments like steroids or antibiotics. As a Phase 4 trial, the research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
You may need to stop certain medications before joining the trial. Specifically, you should not have used systemic immunosuppressive drugs, phototherapy, biologics, topical steroids, or antibiotics within a specified time before starting the study. Check with the trial team for details on your specific medications.
What is the safety track record for Skin Cleanser Combination No.1?
Research shows that mupirocin ointment, an ingredient in Skin Cleanser Combination No.1, is generally safe for treating skin infections like impetigo. The FDA has approved it, confirming its effectiveness and safety for skin use. Some individuals might experience mild burning or stinging at the application site.
The regimen also includes chlorhexidine soap, commonly used in hospitals for skin cleansing. It is usually safe when used as directed, though some individuals might experience skin irritation or dryness.
Lastly, sulfamethoxazole/trimethoprim (Bactrim) is an oral antibiotic commonly used for various infections. It is generally safe but can cause side effects like nausea or rash in some individuals. Serious side effects are rare but possible.
Overall, the components of this cleanser have been used safely in people. However, individual reactions can occur with any treatment. Researchers closely monitor participants in clinical trials to manage any potential side effects.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about this treatment regimen for eczema because it combines a unique mix of antibacterial and antiseptic agents. Unlike standard treatments that often focus solely on reducing inflammation or moisturizing the skin, this regimen includes mupirocin 2% nasal ointment and chlorhexidine 4% topical soap. These ingredients target bacterial colonization, which can exacerbate eczema symptoms. Additionally, the use of sulfamethoxazole/trimethoprim (Bactrim) provides an oral antibiotic approach, potentially reducing skin infections that complicate eczema. This comprehensive strategy has the potential to address both the skin condition and its underlying bacterial issues, offering a fresh angle on eczema management.
What evidence suggests that this skin cleanser might be an effective treatment for eczema?
Research has shown that Skin Cleanser Combination No.1, used by participants in this trial, can help manage eczema by targeting the bacteria Staphylococcus aureus (S. aureus). Studies indicate that mupirocin, a component of this treatment, effectively reduces S. aureus on the skin and in the nose, easing eczema symptoms. Additionally, research suggests that products like chlorhexidine soap can help control skin infections. One study found that using these treatments together can lessen the severity of eczema symptoms. These findings suggest that Skin Cleanser Combination No.1 could improve eczema by reducing bacterial infections on the skin.45678
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a three-week S. aureus decolonization regimen using Mupirocin, Chlorhexidine, and Sulfamethoxazole/trimethoprim
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of disease severity and additional cultures and biopsies
What Are the Treatments Tested in This Trial?
Interventions
- Skin Cleanser Combination No.1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor