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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Dermatitis, Atopic	Drug: tacrolimus ointment	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

Drug Information available for: Tacrolimus

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	166
Study Start Date:	October 2003
Study Completion Date:	February 2005
Primary Completion Date:	February 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: tacrolimus ointment transdermal Other Name: FK506

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.

Eligibility

Ages Eligible for Study:	2 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691262

Locations

Italy

Bologna, Italy, 40100

Catania, Italy, 95124

Genova, Italy, 16100

Lecco, Italy, 23900

Napoli, Italy, 80138

Padova, Italy, 35128

Roma, Italy, 00165

Roma, Italy, 00167

Roma, Italy, 00161

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma Europe BV

More Information

No publications provided

Responsible Party:	Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier:	NCT00691262 History of Changes
Other Study ID Numbers:	FG-506-06-IT-02
Study First Received:	June 3, 2008
Last Updated:	December 8, 2008
Health Authority:	Italy: Ethics Committee

Keywords provided by Astellas Pharma Inc:

Atopic dermatitis
Prograf
Tacrolimus
FK506
Tacrolimus ointment

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013