Tacrolimus Ointment Pharmacokinetics in Infants With Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535691
• Other study ID #: FG-506-06-32
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2007
• Last updated: August 28, 2014
• Start date: April 2003
• Est. completion date: December 2004

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyLatvia: State Agency of MedicinesCanada: Health CanadaIreland: Irish Medicines BoardUnited Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 24 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Tacrolimus Ointment 0.03%
Twice daily, 14 days treatment.
• Tacrolimus Ointment 0.03%
Once daily, 14 days treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Canada,  Finland,  Ireland,  Latvia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy of tacrolimus ointment, evaluated by examination of treated areas.		Day 4, 14 and 18

External Links

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