Status:
WITHDRAWN
Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids Versus Low-Potency Corticosteroid Mono-therapy
Lead Sponsor:
St. Luke's-Roosevelt Hospital Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
9-17 years
Phase:
PHASE4
Brief 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 l...
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...
Eligibility Criteria
Inclusion
- Diagnosis of Atopic Dermatitis
- Ages 9 months to 17 years
- Presence of at least one lesion of atopic dermatitis at the time of baseline enrollment
- Disease limited to less than 100 cm2 body surface area
- EASI Score of at least 7, based on the Gong, et al publication Gong JQ, Lin L, Lin T, Hao F, Zeng FQ, Bi ZG, Yi D, Zhao B. Skin colonization by Staphylococcus aureus in patients with eczema and atopic dermatitis and relevant combined topical therapy: a double-blind multicentre randomized controlled trial. Br J Dermatol. 2006 Oct;155(4):680-7.
Exclusion
- Allergy to any ingredient in Altabax® or Locoid lipocream ®
- Usage of oral corticosteroids within the 2 weeks prior to study initiation or during the study
- Usage of topical corticosteroid or other topical prescriptions for atopic dermatitis in the week prior to study initiation
- Inability to comply with the study protocol
- Presence of major medical illness requiring systemic therapy including cancers.
- Clinical diagnosis of bacterial infections of the skin, including impetigo or abscesses.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00871208
Start Date
May 1 2009
End Date
May 1 2010
Last Update
May 12 2015
Active Locations (3)
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1
Department of Dermatology, Beth Israel Medical Center
New York, New York, United States, 10003
2
Department of Dermatology, Roosevelt Hospital
New York, New York, United States, 10019
3
Department of Dermatology, St. Luke's-Roosevelt-Hospital Center
New York, New York, United States, 10025