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

NCT00179959 | Completed Phase 4 Results

• 1 other identifier: 12624
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Change in Eczema Area and Severity Index (EASI)Scores According to Location

  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).

  Baseline and 3 months

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Intranasal mupirocin ointment and sodium hypochlorite (bleach) baths

Drug: Sodium hypochlorite (bleach) baths; Drug: Mupirocin ointment

Placebo

PLACEBO COMPARATOR

Intranasal petrolatum ointment treatment and plain water baths

Drug: Water; Drug: Petrolatum Ointment

Interventions

Sodium hypochlorite (bleach) baths DRUG

Sodium hypochlorite (bleach) baths twice weekly for 3 months

Also known as: Bleach

Treatment

Mupirocin ointment DRUG

Intranasal mupirocin 2% ointment BID x five days (3 times total for subjects; one time only for family members)

Also known as: Centany

Treatment

Water DRUG

Water baths twice weekly for three months

Also known as: H2O

Placebo

Petrolatum Ointment DRUG

Intranasal petrolatum ointment twice daily for five days

Also known as: Vaseline

Placebo

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Use of cephalexin or other antibiotic in last 6 weeks
• Allergy to cephalosporins

Sponsors & Collaborators

• Northwestern University: lead
• Society for Pediatric Dermatology: collaborator
• Johnson & Johnson: collaborator

Study Sites (1)

Childrens Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Related Publications (1)

• 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. doi: 10.1542/peds.2008-2217.

  PMID: 19403473 RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Sodium Hypochlorite; Baths; Mupirocin; Water; Petrolatum

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Balneology; Therapeutics; Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Hydroxides; Alkalies; Anions; Ions; Electrolytes; Hydrocarbons

Results Point of Contact

• Title: Amy Paller, MD
• Organization: Children's Memorial Hospital

apaller@nmff.org

312-695-6829

Study Officials

• Amy Paller, MD

  Childrens Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Department of Dermatology, Professor of Pediatrics

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2005
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 8, 2014
• Results First Posted: April 29, 2011

Record last verified: 2014-11

Locations

US (1)