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Tacrolimus Ointment Pharmacokinetics in Infants With Atopic Dermatitis

NCT00535691 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2014-09-01

No results posted yet for this study

Summary

The purpose of this study is to estimate the systemic exposure to tacrolimus in infants with atopic dermatitis after repeated application of tacrolimus ointment. Efficacy of tacrolimus ointment, evaluated by examination of treated areas, will also be measured.

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

Tacrolimus Ointment 0.03%

Twice daily, 14 days treatment.

DRUG

Tacrolimus Ointment 0.03%

Once daily, 14 days treatment.

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Central Contact · Astellas Pharma GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Completion
2004-12-31

Countries

  • Canada
  • Finland
  • Ireland
  • Latvia
  • 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 NCT00535691 on ClinicalTrials.gov