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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

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ClinicalTrials.gov Identifier: NCT00691262
Recruitment Status : Completed
First Posted : June 5, 2008
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: tacrolimus ointment Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : October 2003
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: tacrolimus ointment
transdermal
Other Name: FK506



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691262


Locations
Italy
Bologna, Italy, 40100
Catania, Italy, 95124
Genova, Italy, 16100
Lecco, Italy, 23900
Napoli, Italy, 80138
Padova, Italy, 35128
Roma, Italy, 00161
Roma, Italy, 00165
Roma, Italy, 00167
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma Europe B.V.

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00691262     History of Changes
Other Study ID Numbers: FG-506-06-IT-02
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014

Keywords provided by Astellas Pharma Inc:
Atopic dermatitis
Prograf
Tacrolimus
FK506
Tacrolimus ointment

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
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
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action