NCT00871208

Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids Versus Low-Potency Corticosteroid Mono-therapy

Randomized, Placebo-Controlled Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids vs. Low-Potency Corticosteroid Mono-therapy

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: St. Luke's-Roosevelt Hospital Center · Academic / Other
• Sex: All
• Age: 9 Months – 17 Years
• Healthy volunteers: Accepted

Summary

This study is designed to determine whether the addition of topical Altabax (R) to a treatment regimen of topical corticosteroid therapy speeds clearance of atopic dermatitis and improves quality of life.

Detailed description

Background: Atopic dermatitis is a pruritic skin disorder which affects more than 10% of the United States population, one-third of whom report sleep disturbance and a quarter with chronic unremitting disease. Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and extensive costs for the health care system. Quality of life is often impaired for patients with atopic dermatitis due to sleep disturbance, pruritus and the physical impairment of visible skin lesions. The rapidity in which pruritus and lesional appearance are noted to resolve correlates strongly with improved patient satisfaction and improved quality of life. Recently, a clinical trial of adding mupirocin into a regimen of topical corticosteroids has shown a significant enhancement in lesional clearance and symptom reduction with addition of mupirocin to the topical corticosteroid. These improvements were most notable within the first week of treatment. Proposal: A 4-week clinical trial of 60 atopic dermatitis patients (ages 9 months to 17 years) would be conducted. All sixty patients would be given topical mid-potency corticosteroid (Locoid lipocream®) to be mixed with a second product. Half the patients would receive Altabax® and the other half would receive vehicle (blinded to subject and investigator). Patients would be advised to apply the topical randomized product first, let dry and then apply topical Locoid lipocream ® to affected areas, and then apply the topical randomized ointment product to each of the sites of skin disease on top of the Locoid lipocream ®. Treatment of affected areas would continue for 4 weeks or until lesions have cleared, which ever comes first. Parents of patients will be asked to maintain a written diary of drug application.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Altabax (R)	Retapamulin 1% ointment is to be applied to lesional atopic dermatitis twice-daily in addition to a topical corticosteroid (Locoid lipocream (R))
DRUG	Vehicle and Locoid lipocream (R)	The vehicle base of retapamulin ointment will be applied twice-daily to active lesions of atopic dermatitis in addition to locoid lipocream (R)

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-03-30
• Last updated: 2015-05-12

Locations

3 sites across 1 country: United States