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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

Primary Purpose

Dermatitis, Atopic

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

tacrolimus ointment

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Atopic dermatitis, Prograf, Tacrolimus, FK506, Tacrolimus ointment

Eligibility Criteria

2 Years - 15 Years (Child)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 6/end of study (if before month 6) visit

Secondary Outcome Measures

The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 12/end of study (if before month 6) visit

The rate of patients with at least 60% improvement in the Score in Atopic Dermatitis (SCORAD) at month 6/end of study (if before month 6) visit and at month 12/end of study (if after month 6) visit, each compared to baseline (day 1)

Full Information

NCT ID

NCT00691262

First Posted

June 3, 2008

Last Updated

August 29, 2014

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT00691262

Brief Title

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

Official Title

A Long Term, Non-comparative, Multi-centre Study to Further Evaluate the Response to Treatment and Safety of 0.03% Tacrolimus Ointment Administered in Pediatric Patients With Moderate to Severe Atopic Dermatitis.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

February 2005 (Actual)

Study Completion Date

February 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

Keywords

Atopic dermatitis, Prograf, Tacrolimus, FK506, Tacrolimus ointment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

166 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

tacrolimus ointment

Other Intervention Name(s)

FK506

Intervention Description

transdermal

Primary Outcome Measure Information:

Title

The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 6/end of study (if before month 6) visit

Time Frame

1 year

Secondary Outcome Measure Information:

Title

The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 12/end of study (if before month 6) visit

Time Frame

1 year

Title

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Central Contact

Organizational Affiliation

Astellas Pharma Europe B.V.

Official's Role

Study Director

Facility Information:

City

Bologna

ZIP/Postal Code

40100

Country

Italy

City

Catania

ZIP/Postal Code

95124

Country

Italy

City

Genova

ZIP/Postal Code

16100

Country

Italy

City

Lecco

ZIP/Postal Code

23900

Country

Italy

City

Napoli

ZIP/Postal Code

80138

Country

Italy

City

Padova

ZIP/Postal Code

35128

Country

Italy

City

Roma

ZIP/Postal Code

00161

Country

Italy

City

Roma

ZIP/Postal Code

00165

Country

Italy

City

Roma

ZIP/Postal Code

00167

Country

Italy

12. IPD Sharing Statement

Links:

URL

http://www.clinicaltrials.jp/user/ctrSearch_e.jsp

Description

Link to Results on JAPIC - enter 140569 in the JapicCTI-RNo. field

Learn more about this trial

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

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