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10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus (PEER)

This study is currently recruiting participants.
Verified December 2017 by Valeant Pharmaceuticals International, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568997
First Posted: December 6, 2007
Last Update Posted: December 12, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Clinical Research Computing Unit (University of Pennsylvania)
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
  Purpose
This study will examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.

Condition Intervention
Atopic Dermatitis Drug: Pimecrolimus

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Prospective 10 Year Observational Registry of Pediatric Subjects (Age Greater Than or Equal to Two Years to Age Less Than or Equal to 17 Years) With Atopic Dermatitis Who Have Used Elidel Cream 1% (Pimecrolimus)

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • The incidence rate of systemic malignancies in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream [ Time Frame: 10 years of observation with 6-month reporting intervals ]

Secondary Outcome Measures:
  • The incidence rate of lymphoma in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream [ Time Frame: 10 years of observation with 6-month reporting intervals ]
  • The incidence rate of thyroid cancer in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream [ Time Frame: 10 years of observation with 6-month reporting intervals ]
  • The incidence rate of cutaneous malignancy in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream [ Time Frame: 10 years of observation with 6-month reporting intervals ]

Estimated Enrollment: 8000
Actual Study Start Date: June 27, 2005
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2026 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Single-group Open Label Registry of patients exposed to Elidel/Pimecrolimus
Drug: Pimecrolimus
Pimecrolimus 1% cream
Other Name: Elidel

Detailed Description:
Registry study to examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children (ages 2-17 years)
Criteria

Inclusion Criteria:

  • males and females
  • greater than or equal to 2 years and less than or equal to 17 years at enrollment
  • diagnosis of atopic dermatitis (confirmed by treating physician)
  • applied pimecrolimus cream 1 % 6 weeks out of past 24 weeks

Exclusion Criteria:

  • past or present history of systemic malignancy, skin malignancy, or lymphoproliferative disease
  • past or present use of oral immunosuppressive therapy
  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): NCT00568997


Contacts
Contact: Valeant Pharmaceuticals 908-927-1400
Contact: Johnson Varughese 908-927-1162 johnson.varughese@valent.com

Locations
United States, Pennsylvania
Registry Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: NA NA         
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Clinical Research Computing Unit (University of Pennsylvania)
  More Information

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00568997     History of Changes
Other Study ID Numbers: CASM981C2311
First Submitted: December 5, 2007
First Posted: December 6, 2007
Last Update Posted: December 12, 2017
Last Verified: December 2017

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Atopic dermatitis eczema pediatric pimecrolimus malignancy

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
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action