Trial Information

Summary: A Study of Protopic (Tacrolimus) Ointment in Children With Atopic Dermatitis

Status: Completed

Protocol Number: ML18349

Sponsor: Produtos Roche Químicos e Farmacêuticos S.A.

Company Division: Pharmaceutical

Official Scientific Title: An open-label, randomized study of Tacrolimus ointment on clinical response in children with atopic dermatitis

Brief Summary: This study will evaluate the efficacy and safety of Tacrolimus ointment in children with atopic dermatitis. The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals. Target sample size is 170.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

Condition: Atopic Dermatitis

Intervention Type: Drug

Intervention Name: tacrolimus ointment[Protopic]

Primary Outcome: 1. Efficacy: Clinical response (>90% improvement in areas defined for treatment at baseline)

Key Secondary Outcomes: 1. Efficacy: Percent of body surface area affected; Eczema Area and Severity Index; patient's assessment of pruritus Safety: Adverse events

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 2 Years Max: 10 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/29/2005

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:47:13 PM