A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients With Atopic Dermatitis

Astellas Pharma Inc410 enrolled

Overview

The purpose of the study is to determine the impact of topical corticosteroids on the safety and effectiveness of Protopic Ointment in the short-term treatment of moderate to severe Atopic Dermatitis and to compare the safety and effectiveness of Protopic Ointment to placebo in the long-term management of Atopic Dermatitis

Study includes an interim short-term, open label period. Patients could also receive a second course of open label treatment dependent on disease exacerbation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

410

Conditions

Dermatitis, Atopic

Interventions

ProtopicDRUG

topical

CorticosteroidDRUG

topical

placeboDRUG

topical

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient must have Atopic Dermatitis * Patient must be at least 2 years of age Exclusion Criteria: * Patient is pregnant or breast feeding an infant

Locations (24)

Investigational Site

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment

Time frame: 2 weeks

Secondary Outcomes

Percentage of patients reporting cutaneous adverse events overall

Time frame: Day 4 through end of study

Data from ClinicalTrials.gov

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