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Tacrolimus Ointment Pharmacokinetics in Infants With Atopic Dermatitis

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: September 21, 2007
Last updated: August 28, 2014
Last verified: August 2014
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.

Condition Intervention Phase
Dermatitis, Atopic Drug: Tacrolimus Ointment 0.03% Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Multi-centre, Double-blind, Pharmacokinetic Study of Tacrolimus Ointment (0.03%) in Paediatric Patients (Aged 3 Months to 24 Months) With Atopic Dermatitis Following First and Repeated Once Daily or Twice Daily Application of the Tacrolimus Ointment

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Estimate the systemic exposure to tacrolimus after first and repeated application of 0.03% tacrolimus ointment in paediatric patients with atopic dermatitis stratified by application area and randomised to once a day (UID) or twice a day (BID) treatment. [ Time Frame: Day 1 and 14 ]

Secondary Outcome Measures:
  • Efficacy of tacrolimus ointment, evaluated by examination of treated areas. [ Time Frame: Day 4, 14 and 18 ]

Enrollment: 53
Study Start Date: April 2003
Study Completion Date: December 2004
Arms Assigned Interventions
Active Comparator: 1
Tacrolimus ointment 0.03% once daily, placebo once daily
Drug: Tacrolimus Ointment 0.03%
Once daily, 14 days treatment.
Active Comparator: 2
Tacrolimus ointment 0.03% twice daily
Drug: Tacrolimus Ointment 0.03%
Twice daily, 14 days treatment.
Other Name: Protopic 0.03%

Detailed Description:

This is a multi-centre, double-blind, randomised phase II pharmacokinetic study in infants (3 - 24 months old) suffering from atopic dermatitis and requiring treatment with mid potency topical steroids. Patients will primarily be stratified into three groups according to percentage body surface area to be treated and subsequently randomised into treatment groups of once a day (UID) or twice a day (BID) tacrolimus ointment (0.03%) regimens. There will ultimately be a total of six groups. The study will be conducted on an out-patient basis, with each patient's parent/legal representative administering the ointment at home. However all medications on days 1 and 14 will be applied in the clinic by the Investigator or his/her designee, as will the morning application on day 4. The ointment application period will be two weeks with a follow-up period of four days. All patients enrolled into the study, who applied at least one dose of study medication and who benefited from treatment will be given the opportunity to enter a long-term study to follow (FG-506-06-33).

The patient will be entered into one of the following three groups:

Stratification Group I Application area of 5 - 20% Stratification Group II Application area of > 20 - 40% Stratification Group III Application area of > 40%

Within these groups the patients will be randomised to either UID or BID.


Ages Eligible for Study:   3 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient is between 3 and 24 months old on Day 1.
  • The patient has atopic dermatitis requiring treatment with mid potent topical steroids.
  • Patient's disease involves a percentage area to be treated greater than or equal to 5% of the total body surface area

Exclusion Criteria:

  • Patient has clinically infected atopic dermatitis.
  • Patient has a history of more than two courses of systemic corticosteroid treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00535691

Halifax, Canada
Vancouver, Canada
Waterloo, Canada
Helsinki, Finland
Drogheda, Ireland
Dublin, Ireland
Riga, Latvia
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Central Contact Astellas Pharma GmbH
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00535691     History of Changes
Other Study ID Numbers: FG-506-06-32
Study First Received: September 21, 2007
Last Updated: August 28, 2014

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017