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Tacrolimus Ointment Pharmacokinetics in Infants With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00535691
First received: September 21, 2007
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Dermatitis, Atopic
Drug: Tacrolimus Ointment 0.03%
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Efficacy of tacrolimus ointment, evaluated by examination of treated areas. [ Time Frame: Day 4, 14 and 18 ]

Enrollment: 53
Study Start Date: April 2003
Study Completion Date: December 2004
Arms Assigned Interventions
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%

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.

  Eligibility

Ages Eligible for Study:   3 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535691

Locations
Canada
Halifax, Canada
Vancouver, Canada
Waterloo, Canada
Finland
Helsinki, Finland
Ireland
Drogheda, Ireland
Dublin, Ireland
Latvia
Riga, Latvia
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00535691     History of Changes
Other Study ID Numbers: FG-506-06-32
Study First Received: September 21, 2007
Last Updated: August 28, 2014
Health Authority: Finland: Finnish Medicines Agency
Latvia: State Agency of Medicines
Canada: Health Canada
Ireland: Irish Medicines Board
United Kingdom: Department of Health

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Tacrolimus
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014