Study to Evaluate the Response to Treatment and Safety of 0.03% Tacrolimus (FK506) Ointment Administered in Pediatric Patients With Moderate to Severe Atopic Dermatitis

NCT ID: NCT00691262

Last Updated: 2014-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2005-02-28

Brief Summary

Objective of this study is to further assess the response to treatment and safety of 0.03% tacrolimus (FK506) ointment when used for 6 months in pediatric patients with moderate to severe atopic dermatitis, known to be responsive to topical steroids.

Detailed Description

The main phase is 6 month duration, but the follow-up phase up to 12 months will allow the collection of RTT and safety data in a period which will include all seasons in each patient, to account for seasonal variability which strongly affect AD course.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

tacrolimus ointment

Intervention Type: DRUG

transdermal

Interventions

tacrolimus ointment

transdermal

Intervention Type: DRUG

Other Intervention Names

FK506

Eligibility Criteria

Inclusion Criteria

• Patient may be male or female of any ethnic group
• Patient is aged 2 years to 15 years (not having completed his/her 16th birthday) and suffers from moderate to severe atopic dermatitis (Rajka/Langeland score of at least 4.5).
• Patient known to be responsive to topical steroids
• Patient's legal representative has given written informed consent. If the patient is capable of understanding the purposes and risks of the trial written informed consent has been obtained from the patient as well. Female patients of childbearing potential must agree to maintain adequate birth control practice during the trial period and during the first four weeks after the end of the study
• Patient meets the following wash-out criteria:

• Topical corticosteroids
• Systemic corticosteroids (for the treatment of AD only)
• Systemic non-steroidal immunosuppressants (e.g. cyclosporine, methotrexate)
• Other investigational drugs
• Light Treatments (UVA, UVB)
• Patient has not taken/patient and legal representative agree that the patient does not take for the complete study period any medication or therapy prohibited by the protocol

Exclusion Criteria

• Patient has a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
• Patient is pregnant or breast-feeding
• Patient has a skin infection on the affected (and to be treated) area
• Patient has a known hypersensitivity to macrolides in general, to Tacrolimus or any excipient of the ointment
• Patient is simultaneously participating in any other drug trial or less than 28 days have passed between the end of the previous trial and this one
• Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder or condition which, in the opinion of the investigator, may invalidate the communication with the investigator
• Patient is known to be HIV positive

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

Bologna, , Italy

Catania, , Italy

Genova, , Italy

Lecco, , Italy

Napoli, , Italy

Padua, , Italy

Roma, , Italy

Roma, , Italy

Roma, , Italy

Countries

Italy

Other Identifiers

FG-506-06-IT-02

Identifier Type: -

Identifier Source: org_study_id