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

• Status: Withdrawn
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Luke's-Roosevelt Hospital Center
• Collaborator: GlaxoSmithKline
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Hydrocortisone-17-butyrate; Retapamulin

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.