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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.
Information provided by (Responsible Party):
LEO Pharma Identifier:
First received: May 17, 2007
Last updated: July 7, 2016
Last verified: July 2016
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.

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:

Further study details as provided by LEO Pharma:

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 ]

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)
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.

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00475605

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

Responsible Party: LEO Pharma Identifier: NCT00475605     History of Changes
Other Study ID Numbers: F506-CL-5801
FG506-06-37 ( Other Identifier: Sponsor )
03-0-161 ( Other Identifier: Sponsor )
Study First Received: May 17, 2007
Last Updated: July 7, 2016

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

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 May 24, 2017