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

NCT ID: NCT06397781

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-12-31

Brief Summary

Our hypothesis is that S. aureus skin decolonization in atopic dermatitis reduces disease severity and favorably alters the function and gene expression of epidermal and immune skin cells that contribute to disease severity.

Detailed Description

Patients will sign an informed consent and assent to participate. Skin and both nares will be cultured for S aureus. A blood sample and two 2 mm skin biopsies will be obtained one from non-lesional skin and another one from lesional skin). The patients will be instructed in the use of the three-week S. aureus decolonization regimen and provided with the medications (sulfamethoxazole/trimethoprim and Mupirocin ointment) and Chlorhexidine. The second visit will take place immediately at the end of the three-week S. aureus skin decolonization regimen. Disease severity will be assessed, the skin and nares will be re-cultured, and skin biopsies and blood will be obtained.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Skin Cleansing Regimen

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

Group Type: EXPERIMENTAL

Skin Cleanser Combination No.1

Intervention Type: DRUG

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. Dosing for pediatric patients will be calculated to 5 to 6 mg/kg trimethoprim also given twice daily.

Interventions

Skin Cleanser Combination No.1

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. Dosing for pediatric patients will be calculated to 5 to 6 mg/kg trimethoprim also given twice daily.

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wanda Phipatanakul

S. Jean Emans, MD Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Principal Investigator

Role: CONTACT

asthma@childrens.harvard.edu

617-355-6000

Facility Contacts

Principal Investigator, MD, MS

Role: primary

Other Identifiers

IRB-P00047752

Identifier Type: -

Identifier Source: org_study_id