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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00475605
Recruitment Status : Terminated (Terminated early, endorsed by the FDA based on futility of continuation.)
First Posted : May 21, 2007
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Description
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Brief Summary:
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 or disease
Atopic Dermatitis

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.
Study Design
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Study Type : Observational
Actual Enrollment : 8071 participants
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
Actual Study Start Date : May 25, 2005
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Tacrolimus

Groups and Cohorts
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Group/Cohort
1. Protopic Exposure
Pediatric subjects whose ages are/were <16 years at the time of first tacrolimus ointment exposure


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of systemic or cutaneous malignancy [ Time Frame: 10 years ]
    Standardised Incidence Ratio (versus population cancer rates)


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475605


Locations
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Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: LEO Pharma A/S Medical Expert
More Information
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Publications of Results:
D3T01.1J No increased risk of cancer in children using topical tacrolimus for atopic dermatitis: A 10-year prospective cohort study Prof. Dr. Regina Fölster-Holst - Germany 12 October 2019 11:00 - 11:15 EADV 2019

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00475605    
Other Study ID Numbers: F506-CL-5801
FG506-06-37 ( Other Identifier: Sponsor )
03-0-161 ( Other Identifier: Sponsor (Astellas) )
EUPAS ( Registry Identifier: EUPAS12360 )
LP0156-1294 ( Other Identifier: Sponsor (LEO Pharma A/S) )
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by LEO Pharma:
atopic dermatitis
child
tacrolimus ointment
Protopic Ointment
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases