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Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment

NCT00480896 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2014-09-18

No results posted yet for this study

Summary

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.

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

tacrolimus ointment

Topical application

DRUG

Placebo ointment

Topical application

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Use Central Contact · Universitätsklinikum Frankfurt Zentrum für Dermatologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2005-11-30
Completion
2005-11-30

Countries

  • Belgium
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00480896 on ClinicalTrials.gov