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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06397781
• Other study ID #: IRB-P00047752
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 1, 2024
• Est. completion date: July 1, 2028

Study information

• Verified date: June 2024
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 1, 2028
• Est. primary completion date: May 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Skin Cleanser Combination No.1
Mupirocin 2% nasal ointment to the anterior nares to be applied twice daily Chlorhexidine 4% topical soap (Hibiclens) to be used every other day in the shower or bath from the neck down and then completely rinsed. 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity Scoring of Atopic Dermatitis Index	severity index	3 weeks