Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids Versus Low-Potency Corticosteroid Mono-therapy
|Atopic Dermatitis||Drug: Altabax (R) Drug: Vehicle and Locoid lipocream (R)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized, Placebo-Controlled Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids vs. Low-Potency Corticosteroid Mono-therapy|
- Superiority of drug to vehicle in reducing Eczema Area and Severity Index (EASI) scores in children with atopic dermatitis [ Time Frame: Each patient will be enrolled for a 4 week trial ]
- Improved quality of life with usage of the drug altabax (R) and topical corticosteroids over vehicle and topical corticosteroids for treatment of atopic dermatitis in children with atopic dermatitis. [ Time Frame: 4 week trial of medication ]
|Study Start Date:||May 2009|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Altabax (R) and Locoid Lipocream (R):Patients will apply both drugs sequentially to active lesions of atopic dermatitis. Physical examination, skin cultures, photos and quality of life scores will be performed at baseline, week 1, week 2 and week 4.
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))
Active Comparator: 2
Vehicle and Locoid Lipocream (R):Patients will apply both drugs sequentially to active lesions of atopic dermatitis. Physical examination, skin cultures, photos and quality of life scores will be performed at baseline, week 1, week 2 and week 4.
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)
Other Name: Locoid lipocream (R)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00871208
|United States, New York|
|Department of Dermatology, Beth Israel Medical Center|
|NY, New York, United States, 10003|
|Department of Dermatology, Roosevelt Hospital|
|NY, New York, United States, 10019|
|Department of Dermatology, St. Luke's-Roosevelt-Hospital Center|
|NY, New York, United States, 10025|