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

NCT06397781 | Not Yet Recruiting Phase 4

• 1 other identifier: IRB-P00047752
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Severity Scoring of Atopic Dermatitis Index

  severity index

  3 weeks

Study Arms (1)

Skin Cleansing Regimen

EXPERIMENTAL

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

Drug: Skin Cleanser Combination No.1

Interventions

Skin Cleanser Combination No.1 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.

Skin Cleansing Regimen

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants ≥6 yrs of age
• Meet atopic dermatitis Standard Diagnostic Criteria
• SCORAD \> 40.

You may not qualify if:

• Enrollment in another clinical trial
• Hypersensitivity to an agent used for the skin decolonization protocol
• Use within 4 weeks of systemic treatment with immunosuppressive/immunomodulating drugs (corticosteroids, cyclosporine, mycophenolate, azathioprine, methotrexate)
• Phototherapy for AD within 4 weeks
• Treatment with biologics (dupilumab, omalizumab, benralizumab, etc) within sixteen weeks
• Use of topical steroids, topical calcineurin inhibitors within 7 days
• Bleach baths within 7 days of the first Visit
• Use of oral or topical antibiotics within 21 days of the beginning of the study
• Asthmatics receiving more than 500 μg per day of inhaled corticosteroids
• History of (HIV, hepatitis B, hepatitis C, tuberculosis malignancy
• Skin comorbidities that may interfere with assessments: psoriasis, cutaneous T Cell lymphoma,,
• Severe ongoing medical illnesses e.g. cardiovascular, renal disease, autoimmune disease.
• Febrile illness at time of visits
• Suspected immune deficiency or family history of primary immunodeficiency
• Pregnancy

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Principal Investigator

CONTACT

617-355-6000; asthma@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: S. Jean Emans, MD Professor of Pediatrics

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start (Estimated): January 1, 2031
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2039
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)