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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 : Active, not recruiting
First Posted : May 21, 2007
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Type : Observational
Actual Enrollment : 8037 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
Study Start Date : May 2005
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Tacrolimus
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

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


  Show 313 Study Locations
Sponsors and Collaborators
LEO Pharma
Investigators
Study Director: Medical Director Astellas Pharma Global Development
More Information

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00475605     History of Changes
Other Study ID Numbers: F506-CL-5801
FG506-06-37 ( Other Identifier: Sponsor )
03-0-161 ( Other Identifier: Sponsor )
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
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
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action