Effect of S. Aureus Skin Decolonization on Disease Severity in Atopic Dermatitis Patients
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Boston Children's Hospital
- Study ID
- NCT06397781
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Skin Cleanser Combination No.1 — DRUG1. 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.
Study Details
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.
Key Dates
- Start date
- Jan 1, 2031
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2035
- Completion
- Dec 31, 2039
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Skin Cleansing Regimen1. 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
Primary Outcome Measure
Severity Scoring of Atopic Dermatitis Index [ Time Frame: 3 weeks ]
Central Contacts
- Principal Investigator617-355-6000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | Principal Investigator, MD, MS |
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