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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This study has been withdrawn prior to enrollment.
(withdrawn due to contractual issues)
Information provided by (Responsible Party):
University of California, Davis Identifier:
First received: August 24, 2006
Last updated: April 6, 2015
Last verified: April 2015
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
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 ]

Enrollment: 0
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.

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

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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Please refer to this study by its identifier: NCT00368719

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

Additional Information:
Responsible Party: University of California, Davis Identifier: NCT00368719     History of Changes
Other Study ID Numbers: 200614402-1
Study First Received: August 24, 2006
Last Updated: April 6, 2015

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017