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Evaluation to Assess the Long Term Safety of Tacrolimus Ointment for Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00368719
Recruitment Status : Withdrawn (withdrawn due to contractual issues)
First Posted : August 25, 2006
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
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Brief Summary:
To assess the long-term safety of tacrolimus ointment

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Tacrolimus Phase 4

Detailed Description:
To assess the long-term safety of tacrolimus ointment 0.03% or 0.1% in the treatment of subjects with atopic dermatitis under actual use conditions, including the risk of developing cutaneous or systemic malignancies. The FDA and EMEA approved Tacrolimus ointment, 0.03% in children and 0.1% and 0.03% in adults, for the treatment of atopic dermatitis. As part of the approval process, the FDA and EMEA requested a post-marketing commitment regarding the safety of long-term use of Tacrolimus ointment in pediatric atopic dermatitis subjects.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: APPLES: A Prospective Pediatric Longitudinal Evaluation To Assess The Long Term Safety Of Tacrolimus Ointment For The Treatment Of Atopic Dermatitis
Study Start Date : September 2007
Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Tacrolimus

Arms and Interventions
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Arm Intervention/treatment
No Intervention: 1 Drug: Tacrolimus
Participants will be followed for 10 years to study the effects of Tacrolimus.


Outcome Measures
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Primary Outcome Measures :
  1. The purpose of this study is to identify the long term effects of Tacrolimus in pediatric subjects [ Time Frame: 10 Years ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject has/had atopic dermatitis.
  • Subject has applied tacrolimus ointment 0.03% or 0.1% for at least 6 weeks, continuously or intermittently. This may include subjects who have been enrolled in previous tacrolimus ointment studies and/or subjects with commercial product exposure prior to study enrollment.
  • Subject age at the first tacrolimus ointment exposure is/was <16 years of age.
  • Subject/Caregiver has given written informed consent and assent as required by state and/or governmental laws, including access to all relevant clinical and medication data, and the storage and analysis of these data.
  • Subject/Caregiver agrees to comply with the program requirements including an annual physical exam and biennial dermatological exam and agrees to be contacted and provide information as described in this document to Primary Investigator Dr. Lamb and Covance Periapproval Services, Inc.

Exclusion Criteria:

  • Subjects who do not have/ have not had Atopic Dermatitis.
  • Subjects must have used Tacrolimus ointment prior to age 16.
Contacts and Locations
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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): NCT00368719


Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Fu-Tong Liu, M.D., Ph.D. Physician with UC Davis Department of Dermatology
More Information
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Additional Information:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00368719    
Other Study ID Numbers: 200614402-1
First Posted: August 25, 2006    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
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