Clinical trial NCT00871208: Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids Versus Low-Potency Corticosteroid Mono-therapy
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
pruritus
quality of life
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-03-30
Enrollment: 0
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Atopic Dermatitis
2. Ages 9 months to 17 years
3. Presence of at least one lesion of atopic dermatitis at the time of baseline enrollment
4. Disease limited to less than 100 cm2 body surface area
5. 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 Criteria:

1. Allergy to any ingredient in Altabax® or Locoid lipocream ®
2. Usage of oral corticosteroids within the 2 weeks prior to study initiation or during the study
3. Usage of topical corticosteroid or other topical prescriptions for atopic dermatitis in the week prior to study initiation
4. Inability to comply with the study protocol
5. Presence of major medical illness requiring systemic therapy including cancers.
6. Clinical diagnosis of bacterial infections of the skin, including impetigo or abscesses.

Primary outcomes:
measure: Superiority of drug to vehicle in reducing Eczema Area and Severity Index (EASI) scores in children with atopic dermatitis
timeFrame: Each patient will be enrolled for a 4 week trial
Secondary outcomes:
measure: 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.
timeFrame: 4 week trial of medication
Other outcomes:
Locations:
city: NY
country: United States
facility: Department of Dermatology, Beth Israel Medical Center
state: New York
city: NY
country: United States
facility: Department of Dermatology, Roosevelt Hospital
state: New York
city: NY
country: United States
facility: Department of Dermatology, St. Luke's-Roosevelt-Hospital Center
state: New York
Study officials:
References:
citation: Fivenson D, Arnold RJ, Kaniecki DJ, Cohen JL, Frech F, Finlay AY. The effect of atopic dermatitis on total burden of illness and quality of life on adults and children in a large managed care organization. J Manag Care Pharm. 2002 Sep-Oct;8(5):333-42. doi: 10.18553/jmcp.2002.8.5.333.
citation: Carroll CL, Balkrishnan R, Feldman SR, Fleischer AB Jr, Manuel JC. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol. 2005 May-Jun;22(3):192-9. doi: 10.1111/j.1525-1470.2005.22303.x.
citation: Ricci G, Bendandi B, Bellini F, Patrizi A, Masi M. Atopic dermatitis: quality of life of young Italian children and their families and correlation with severity score. Pediatr Allergy Immunol. 2007 May;18(3):245-9. doi: 10.1111/j.1399-3038.2006.00502.x.
citation: 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. doi: 10.1111/j.1365-2133.2006.07410.x.