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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00691262
First received: June 3, 2008
Last updated: August 29, 2014
Last verified: August 2014

June 3, 2008
August 29, 2014
October 2003
February 2005   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00691262 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dermatitis, Atopic
Drug: tacrolimus ointment
transdermal
Other Name: FK506
Experimental: 1
Intervention: Drug: tacrolimus ointment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
166
February 2005
February 2005   (final data collection date for primary outcome measure)

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
Both
2 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00691262
FG-506-06-IT-02
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Central Contact Astellas Pharma Europe B.V.
Astellas Pharma Inc
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP