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 — 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.

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 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

Primary Outcome Measure

Severity Scoring of Atopic Dermatitis Index [ Time Frame: 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Principal Investigator, MD, MS

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