Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment

Astellas Pharma Inc250 enrolled

Overview

A long-term 0.03% tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis, and prevent, delay, and reduce flares.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

250

Conditions

Dermatitis, Atopic

Interventions

tacrolimus ointmentDRUG

Topical application

Placebo ointmentDRUG

Topical application

Eligibility

Sex: ALLMin age: 2 YearsMax age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female patient of any ethnic group * Patient was at least 2-15 years old and suffered from mild to severe atopic dermatitis (Rajka/Langeland score of at least 3) Exclusion Criteria: * Patient had a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma * Patient had a clinically significant skin infection on the affected (and to be treated) area

Locations (22)

Unnamed facility

Brussels, Belgium

Unnamed facility

Brno, Czechia

3 Sites

Prague, Czechia

Outcomes

Primary Outcomes

Number of exacerbations of atopic dermatitis requiring intervention.

Time frame: 12 months

Secondary Outcomes

Time to first exacerbation requiring intervention; exacerbation treatment days, periods and time to first exacerbation; physician and patient assessment of affected area, treatment response; quality of life; global response.

Time frame: 12 months

Data from ClinicalTrials.gov

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