Long-term Safety of Protopic in Atopic Eczema

Dermatitis, Atopic Clinical Trial

Official title:

A Long-term, Open Label, Noncomparative Study to Evaluate the Safety of 0.1% Tacrolimus (FK506) Ointment for Treatment of Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560378
• Other study ID #: FG-506-06-21
• Status: Completed
• Phase: Phase 3
• First received: November 16, 2007
• Last updated: September 17, 2014
• Start date: June 1998
• Est. completion date: June 2005

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the EnvironmentDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyIreland: Irish Medicines BoardLatvia: State Agency of MedicinesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema are entitled to enter this four-year follow study to investigate the safety of treatment with Tacrolimus ointment 0.1%

Description:

A long-term, multi-centre, open label, non-comparative phase III study in patients with atopic dermatitis. All centres in Europe which have participated or are still participating in the FG-506-06-12, FG-506-06-18 or FG-506-06-19, FG-506-06-22 or FG-506-06-23 studies will be offered a participation in the protocol. Only patients enrolled by those centres for the above mentioned studies, who have received at least one dose of study medication can be enrolled. Tacrolimus ointment 0.1% will be administered until clearance of the skin occurs. Treatment is restarted after signs and symptoms reoccur. Safety will be assessed from adverse events reported by the patient/parent/guardian or observed by the investigator at the site of application and elsewhere. The safety evaluation will include monitoring of routine hematology and serum chemistry parameters at Baseline/Day 1, Week 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and/or at the end of the study (End-of-Study Visit).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 789
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Every patient who has participated in the FG-506-06-12, FG-506-06-18, FG-506-06-19, FG-506-06-22 or FG-506-06-23 study, and has received at least one dose of study medication

• Patient is likely to benefit from further treatment with Tacrolimus (FK506) ointment in the opinion of the investigator

• Patient has atopic dermatitis with Body surface involvement between 5% and 60% for patients with the age of 2 years to 15 years (not having reached their 16th birthday) and between 5% and 100% for patients with 16 years of age or older

Exclusion Criteria:

• Patient has an infection requiring treatment

• Patient is known to be HIV positive

• Patient has a systemic disease, including cancer or history of cancer or AIDS, which would contraindicate the use of Tacrolimus (FK506) ointment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Eczema, Atopic

Intervention

Drug:
• Tacrolimus ointment 0.1%
Topical

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Belgium,  Denmark,  Finland,  France,  Germany,  Hungary,  Ireland,  Latvia,  Netherlands,  Poland,  Spain,  United Kingdom, 

References & Publications (1)

Reitamo S, Rustin M, Harper J, Kalimo K, Rubins A, Cambazard F, Brenninkmeijer EE, Smith C, Berth-Jones J, Ruzicka T, Sharpe G, Taieb A; 0.1% Tacrolimus Ointment Long-term Follow-up Study Group. A 4-year follow-up study of atopic dermatitis therapy with 0.1% tacrolimus ointment in children and adult patients. Br J Dermatol. 2008 Sep;159(4):942-51. doi: 10.1111/j.1365-2133.2008.08747.x. Epub 2008 Jul 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		4 Years
Secondary	Haematology and biochemistry parameters and vital signs		4 Years

External Links

•   Link to Results on JAPIC - enter 140600 in the JapicCTI-RNo. field