Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06397781

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location contact

Principal Investigator, MD, MS

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • . 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

Treatment and study plan

Skin Cleanser Combination No.1

Drug
  • 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.

Primary outcomes

  1. Severity Scoring of Atopic Dermatitis Index

    Time frame: 3 weeks

    severity index

Study contacts

Contact information is provided by the study sponsor or research team.

Principal Investigator

CONTACT

[email protected]

617-355-6000

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2031
Primary completion
2035
Study completion
2039
First posted
May 3, 2024
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.