Tacrolimus Ointment Pharmacokinetics in Infants With Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT00535691|
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : September 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Dermatitis, Atopic||Drug: Tacrolimus Ointment 0.03%||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||April 2003|
|Actual Study Completion Date :||December 2004|
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%
- 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 ]
- Efficacy of tacrolimus ointment, evaluated by examination of treated areas. [ Time Frame: Day 4, 14 and 18 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535691
|London, United Kingdom|
|Study Chair:||Central Contact||Astellas Pharma GmbH|