Tacrolimus Ointment Pharmacokinetics in Infants With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00535691
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : September 1, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

September 21, 2007
September 26, 2007
September 1, 2014
April 2003
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00535691 on Archive Site
Efficacy of tacrolimus ointment, evaluated by examination of treated areas. [ Time Frame: Day 4, 14 and 18 ]
Same as current
Not Provided
Not Provided
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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Dermatitis, Atopic
  • Drug: Tacrolimus Ointment 0.03%
    Twice daily, 14 days treatment.
    Other Name: Protopic 0.03%
  • Drug: Tacrolimus Ointment 0.03%
    Once daily, 14 days treatment.
  • Active Comparator: 1
    Tacrolimus ointment 0.03% once daily, placebo once daily
    Intervention: Drug: Tacrolimus Ointment 0.03%
  • Active Comparator: 2
    Tacrolimus ointment 0.03% twice daily
    Intervention: Drug: Tacrolimus Ointment 0.03%
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2004
Not Provided

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
Sexes Eligible for Study: All
3 Months to 24 Months   (Child)
Contact information is only displayed when the study is recruiting subjects
Canada,   Finland,   Ireland,   Latvia,   United Kingdom
Not Provided
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Central Contact Astellas Pharma GmbH
Astellas Pharma Inc
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP