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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 currently recruiting participants.
Verified by Astellas Pharma Inc, July 2008

Sponsored by: Astellas Pharma Inc
Information provided by: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00475605
  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

ChemIDplus related topics:   Tacrolimus    Tacrolimus anhydrous   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   8000
Study Start Date:   May 2005
Estimated Study Completion Date:   December 2023
Estimated Primary Completion Date:   December 2023 (Final data collection date for primary outcome measure)

Groups/Cohorts
1
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

Contacts
Contact: APPLES Study Line     (877) 277-7530     clintrials.info@us.astellas.com    

Show 329 study locations  Show 329 Study Locations

Sponsors and Collaborators
Astellas Pharma Inc

Investigators
Study Director:     Use Central Contact     Astellas Pharma US, Inc.    
  More Information

Responsible Party:   Astellas Pharma US, Inc ( Sr Manager Clinical Trials Registry )
Study ID Numbers:   03-0-161, FG506-06-37
First Received:   May 17, 2007
Last Updated:   July 31, 2008
ClinicalTrials.gov Identifier:   NCT00475605
Health Authority:   United States: Food and Drug Administration;   European Union: European Medicines Agency

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

Study placed in the following topic categories:
Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Tacrolimus
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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