Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00560326
First received: November 16, 2007
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment as long-term treatment in paediatric patients with atopic dermatitis.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term, Non-comparative Study to Evaluate the Safety and Efficacy of Tacrolimus Oint¬Ment in Paediatric Patients

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Assess safety from observations of adverse events, laboratory examinations, pulse, height, weight and tacrolimus blood concentrations [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Assess efficacy from parameters as follows: - Physician's global evaluation of clinical response - Physician's assessment of individual signs - Affected area - Parent/guardian's assessment of global response - EASI [ Time Frame: 24 months ]

Enrollment: 50
Study Start Date: June 2003
Study Completion Date: December 2006
Arms Assigned Interventions
Experimental: 1 Drug: Tacrolimus Ointment 0.03%
Once or twice daily topical application
Other Name: Protopic 0.03%

Detailed Description:

This is a long-term, multi-centre, non-comparative phase II study. All centres participating in the FG-506-06-32 pharmacokinetics study will be offered the protocol as a follow-up. Only patients enrolled by those centres for the above mentioned study, who applied at least one dose of study medication and benefited from treatment with 0.03% tacrolimus ointment, can be enrolled.

During episodes of active disease, a thin coat of ointment is applied on each lesion. In the first three weeks, frequency of application is twice a day; after three weeks treatment is continued once a day. All atopic dermatitis lesions are treated until clearance (i.e. itch has gone). In case of a flare-up or worsening treatment twice daily treatment is re-started for three weeks and thereafter reduced to once daily.

Safety is assessed from adverse events reported by the patient and/or his parents or observed by the investigator at the site of application and elsewhere. The safety evaluation includes monitoring of routine haematology and serum chemistry parameters. Blood samples are analysed by local laboratories. Blood samples are taken to determine concentrations of tacrolimus.

Height, weight and pulse of the patient are recorded at each visit.

Efficacy is assessed by physician's global evaluation of clinical response, patient's parent/guardian's assessment of global response, physician's assessment of individual signs and the affected area assessment.

  Eligibility

Ages Eligible for Study:   6 Months to 30 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has participated in the study FG-506-06-32, has applied at least one dose of study medication and has benefited from treatment in the opinion of the investigator.
  • Patient is likely to benefit from further treatment with tacrolimus ointment in the opinion of the investigator.

Exclusion Criteria:

  • Patient has a skin disorder on the affected (and to be treated) area, other than atopic dermatitis, requiring treatment.
  • Patient has clinically infected atopic dermatitis.
  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: NCT00560326

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 Europe B.V.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00560326     History of Changes
Other Study ID Numbers: FG-506-06-33
Study First Received: November 16, 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

Keywords provided by Astellas Pharma Inc:
Paediatric patients
Tacrolimus
Dermatitis, Atopic

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 October 22, 2014