The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis

This study has been completed.
Sponsor:
Collaborators:
Society for Pediatric Dermatology
Johnson & Johnson
Information provided by (Responsible Party):
Amy Paller, Northwestern University
ClinicalTrials.gov Identifier:
NCT00179959
First received: September 13, 2005
Last updated: November 29, 2012
Last verified: October 2012
  Purpose

Staphylococcus aureus (S. aureus) infection is perceived not only as a common secondary complication of atopic dermatitis (AD), but also as a culprit in the worsening of this condition. In addition, the recent development of community acquired methicillin-resistant S. aureus (CA-MRSA) has presented a new challenge to our management of AD, both in treatment of acute infections and maintenance therapy. The investigators would like to perform a randomized investigator-blinded placebo-controlled study of children aged 6 months to 17 years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the relationship of sensitivity of the S. aureus organism cultured from the infected lesion(s) to clinical response to oral cephalexin therapy and severity of the AD; and 3) whether concurrent treatment of S. aureus infection initially with nasal mupirocin ointment and sodium hypochlorite (bleach) baths can result in long-term S. aureus eradication and clinical stability.


Condition Intervention Phase
Atopic Dermatitis
Drug: Sodium hypochlorite (bleach) baths
Drug: Mupirocin ointment
Drug: Water
Drug: Petrolatum Ointment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in Eczema Area and Severity Index (EASI)Scores According to Location [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    The proportion of affected body surface area (BSA) was estimated from 4 designated body regions(head/neck, upper limbs, trunk, and lower limbs),and the Physician's Assessment of Individual Signs was determined for each region by grading signs of AD on a 4-point scale. Both the proportion of affected BSA and the Physician's Assessment of Individual Signs score were used to calculate the EASI score,a validated composite score that ranges from 0 (clear) to 72 (very severe).


Enrollment: 31
Study Start Date: September 2005
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment
Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
Drug: Sodium hypochlorite (bleach) baths
Sodium hypochlorite baths twice weekly for three months
Other Name: Bleach
Drug: Mupirocin ointment
Intranasal mupirocin 2% ointment BID x five days (3 times total for subjects; one time only for family members)
Other Name: Centany
Placebo Comparator: Placebo
Intranasal petrolatum ointment treatment and plain water baths
Drug: Water
Water baths twice weekly for three months
Drug: Petrolatum Ointment
Intranasal petrolatum ointment twice daily for five days
Other Name: Vaseline

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 months to 17 years of age
  • Moderate to severe atopic dermatitis

Exclusion Criteria:

  • Use of cephalexin or other antibiotic in last 6 weeks
  • Allergy to cephalosporins
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179959

Locations
United States, Illinois
Childrens Memorial Hospital
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Northwestern University
Society for Pediatric Dermatology
Johnson & Johnson
Investigators
Principal Investigator: Amy Paller, MD Childrens Memorial Hospital
  More Information

Publications:
Responsible Party: Amy Paller, Professor and Chair of Department of Dermatology, Professor of Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT00179959     History of Changes
Other Study ID Numbers: 12624
Study First Received: September 13, 2005
Results First Received: April 4, 2011
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Sodium Hypochlorite
Eusol
Mupirocin
Petrolatum
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Emollients
Dermatologic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 23, 2014