Tacrolimus Ointment Pharmacokinetics in Infants With Atopic Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Tacrolimus ointment 0.03% once daily, placebo once daily

Group Type ACTIVE_COMPARATOR

Tacrolimus Ointment 0.03%

Intervention Type DRUG

Once daily, 14 days treatment.

2

Tacrolimus ointment 0.03% twice daily

Group Type ACTIVE_COMPARATOR

Tacrolimus Ointment 0.03%

Intervention Type DRUG

Twice daily, 14 days treatment.

Interventions

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Tacrolimus Ointment 0.03%

Twice daily, 14 days treatment.

Intervention Type DRUG

Tacrolimus Ointment 0.03%

Once daily, 14 days treatment.

Intervention Type DRUG

Other Intervention Names

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Protopic 0.03%

Eligibility Criteria

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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