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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179959
First Posted: September 16, 2005
Last Update Posted: December 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Society for Pediatric Dermatology
Johnson & Johnson
Information provided by (Responsible Party):
Amy Paller, Northwestern University
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Amy Paller, Northwestern University:

Primary Outcome Measures:
  • Change in Eczema Area and Severity Index (EASI)Scores According to Location [ Time Frame: Baseline and 3 months ]
    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 and sodium hypochlorite (bleach) baths
Drug: Sodium hypochlorite (bleach) baths
Sodium hypochlorite (bleach) baths twice weekly for 3 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
Other Name: H2O
Drug: Petrolatum Ointment
Intranasal petrolatum ointment twice daily for five days
Other Name: Vaseline

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: April 4, 2011
Results First Posted: April 29, 2011
Last Update Posted: December 8, 2014
Last Verified: November 2014

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