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

History of Changes

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:

MedlinePlus related topics: Drinking Water

Drug Information available for: Sodium hypochlorite Petrolatum Mupirocin Staphylococcus aureus Mupirocin calcium

U.S. FDA Resources

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:

Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14.

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 May 19, 2013

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