Trial information
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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
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:
- children 2-10 years of age;
- mild to severe atopic dermatitis.
Exclusion criteria:
- skin disorder other than atopic dermatitis;
- previous treatment with tacrolimus ointment in a clinical study;
- known diagnosis or history of cancer, including skin cancer, or human immunodeficiency virus (HIV);
- clinically infected atopic dermatitis.
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: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Brazil
- Belo Horizonte
- Guarulhos
- Porto Alegre
- Sao Paulo
