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

Primary Purpose

Atopic Dermatitis

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tacrolimus
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

2 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    No Intervention

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    The purpose of this study is to identify the long term effects of Tacrolimus in pediatric subjects

    Secondary Outcome Measures

    Full Information

    First Posted
    August 24, 2006
    Last Updated
    April 6, 2015
    Sponsor
    University of California, Davis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00368719
    Brief Title
    Evaluation to Assess the Long Term Safety of Tacrolimus Ointment for Atopic Dermatitis
    Official Title
    APPLES: A Prospective Pediatric Longitudinal Evaluation To Assess The Long Term Safety Of Tacrolimus Ointment For The Treatment Of Atopic Dermatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    withdrawn due to contractual issues
    Study Start Date
    September 2007 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2016 (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Davis

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To assess the long-term safety of tacrolimus ointment
    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Tacrolimus
    Intervention Description
    Participants will be followed for 10 years to study the effects of Tacrolimus.
    Primary Outcome Measure Information:
    Title
    The purpose of this study is to identify the long term effects of Tacrolimus in pediatric subjects
    Time Frame
    10 Years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fu-Tong Liu, M.D., Ph.D.
    Organizational Affiliation
    Physician with UC Davis Department of Dermatology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.ucdmc.ucdavis.edu/dermatology/research/clinical
    Description
    University of California-Davis Department of Dermatology Clinical Research

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

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