Effect of S. Aureus Skin Decolonization on Disease Severity in Atopic Dermatitis Patients

Launched by BOSTON CHILDREN'S HOSPITAL · Apr 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a treatment that reduces Staphylococcus aureus (S. aureus), a type of bacteria often found on the skin, can help lessen the severity of atopic dermatitis, a common skin condition that causes itching and inflammation. The researchers believe that by cleaning the skin of this bacteria, it may improve how skin and immune cells function, leading to better outcomes for patients.

To participate in the trial, individuals must be at least 6 years old and have a confirmed diagnosis of atopic dermatitis that is quite severe. However, some people may not be eligible, including those currently in another clinical trial or those who have used specific treatments recently, such as certain medications or therapies for their skin condition. If eligible, participants can expect to follow a skin decolonization protocol and will be monitored for changes in their condition. This trial is not yet recruiting, so more information will be available as it progresses.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female participants ≥6 yrs of age
• • 2. Meet atopic dermatitis Standard Diagnostic Criteria
• • 3. SCORAD \> 40.
• Exclusion Criteria:
• • 1. . Enrollment in another clinical trial
• • 2. Hypersensitivity to an agent used for the skin decolonization protocol
• • 3. Use within 4 weeks of systemic treatment with immunosuppressive/immunomodulating drugs (corticosteroids, cyclosporine, mycophenolate, azathioprine, methotrexate)
• • 4. Phototherapy for AD within 4 weeks
• • 5. Treatment with biologics (dupilumab, omalizumab, benralizumab, etc) within sixteen weeks
• • 6. Use of topical steroids, topical calcineurin inhibitors within 7 days
• • 7. Bleach baths within 7 days of the first Visit
• • 8. Use of oral or topical antibiotics within 21 days of the beginning of the study
• • 9. Asthmatics receiving more than 500 μg per day of inhaled corticosteroids
• • 10. History of (HIV, hepatitis B, hepatitis C, tuberculosis malignancy
• • 11. Skin comorbidities that may interfere with assessments: psoriasis, cutaneous T Cell lymphoma,,
• • 12. Severe ongoing medical illnesses e.g. cardiovascular, renal disease, autoimmune disease.
• • 13. Febrile illness at time of visits
• • 14. Suspected immune deficiency or family history of primary immunodeficiency
• • 15. Pregnancy