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

This study has been withdrawn prior to enrollment.
(withdrawn due to contractual issues)
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00368719
First received: August 24, 2006
Last updated: May 7, 2009
Last verified: May 2009
  Purpose

To assess the long-term safety of tacrolimus ointment


Condition Intervention Phase
Atopic Dermatitis
Drug: Tacrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • The purpose of this study is to identify the long term effects of Tacrolimus in pediatric subjects [ Time Frame: 10 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2007
Estimated Study Completion Date: July 2016
Arms Assigned Interventions
No Intervention: 1 Drug: Tacrolimus
Participants will be followed for 10 years to study the effects of Tacrolimus.

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.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368719

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

No publications provided

Responsible Party: Fu-Tong Liu, University of California Davis
ClinicalTrials.gov Identifier: NCT00368719     History of Changes
Other Study ID Numbers: 200614402-1
Study First Received: August 24, 2006
Last Updated: May 7, 2009
Health Authority: United States: Institutional Review Board

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 August 27, 2014