Tacrolimus Ointment Pharmacokinetics in Infants With Atopic Dermatitis

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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: Tacrolimus Ointment 0.03%; Drug: Tacrolimus Ointment 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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Halifax, Canada
  • Vancouver, Canada
  • Waterloo, Canada
• Finland
  • Helsinki, Finland
• Ireland
  • Drogheda, Ireland
  • Dublin, Ireland
• Latvia
  • Riga, Latvia
• United Kingdom
  • London, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Tacrolimus ointment 0.03% once daily, placebo once daily	Drug: Tacrolimus Ointment 0.03%; Twice daily, 14 days treatment.; Other Names: Protopic 0.03%; 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 Names: Protopic 0.03%; Drug: Tacrolimus Ointment 0.03%; Once daily, 14 days treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Day 1 and 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacy of tacrolimus ointment, evaluated by examination of treated areas.	Day 4, 14 and 18

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Chair: Central Contact, Astellas Pharma GmbH

Publications and helpful links

Helpful Links

• Link to Results on JAPIC - enter 140563 in the JapicCTI-RNo. field

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion: December 7, 2022
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: September 21, 2007
• First Submitted That Met QC Criteria: September 24, 2007
• First Posted (Estimate): September 26, 2007

Study Record Updates

• Last Update Posted (Estimate): September 1, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: FG-506-06-32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No