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A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis (APPLES)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00475605
First received: May 17, 2007
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  Purpose

This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.


Condition
Atopic Dermatitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:

Drug Information available for: Tacrolimus
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • The endpoint is the occurrence of serious adverse events, including the observation of systemic and cutaneous malignancies [ Time Frame: At six month intervals for ten years ] [ Designated as safety issue: No ]

Enrollment: 8037
Study Start Date: May 2005
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts
1. Protopic Exposure
Pediatric subjects whose ages are/were <16 years at the time of first tacrolimus ointment exposure

Detailed Description:

Data will be collected at enrollment and every 6 months thereafter either by interview, Internet, or physician office visit. Each subject will be followed for 10 years in this study.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric subjects whose ages are/were <16 years at the time of first tacrolimus ointment exposure

Criteria

Inclusion Criteria:

  • Subjects who first used Protopic® 0.03% or 0.1% before they were sixteen years of age and were treated for at least 6 weeks for the treatment of Atopic dermatitis may enroll into the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475605

  Show 308 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00475605     History of Changes
Other Study ID Numbers: F506-CL-5801, FG506-06-37, 03-0-161
Study First Received: May 17, 2007
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
Protopic Ointment
tacrolimus ointment
atopic dermatitis
child

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 May 23, 2013