CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31 enrolled
Drug / intervention
Sodium hypochlorite (bleach) baths +3 moredrug
Likely dose
Sodium hypochlorite (bleach) baths twice weekly for 3 months; intranasal mupirocin 2% ointment twice daily for 5 days (3 times total); or water/petrolatum control regimensAI-extracted
Key inclusion· 2
  • Age 6 months to 17 years
  • Moderate to severe atopic dermatitis
Key exclusion· 2
  • Use of cephalexin or other antibiotic in the last 6 weeks
  • Allergy to cephalosporins

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00179959
NCT00179959Phase 4Completed

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

Northwestern University·interventional·Posted Sep 16, 2005·Updated Dec 8, 2014

In Brief

A Phase 4 clinical trial evaluating Sodium hypochlorite (bleach) baths, Mupirocin ointment, and 2 other interventions for Atopic Dermatitis. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartSep 1, 2005
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 20.8 years ago

Interventions

Sodium hypochlorite (bleach) bathsdrug

Sodium hypochlorite (bleach) baths twice weekly for 3 months

Mupirocin ointmentdrug

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

Waterdrug

Water baths twice weekly for three months

Petrolatum Ointmentdrug

Intranasal petrolatum ointment twice daily for five days