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

Astellas

Status and phase

Completed

Phase 3

Conditions

Dermatitis, Atopic

Treatments

Drug: tacrolimus ointment

Study type

Interventional

Funder types

Industry

Identifiers

NCT00691262

FG-506-06-IT-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

166 patients

Sex

All

Ages

2 to 15 years old

Volunteers

No Healthy Volunteers

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