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

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.
 
ClinicalTrials.gov Identifier: NCT00568997
Recruitment Status : Recruiting
First Posted : December 6, 2007
Last Update Posted : December 15, 2021
Sponsor:
Collaborator:
Clinical Research Computing Unit (University of Pennsylvania)
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Description
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Brief Summary:
This study will examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.

Condition or disease Intervention/treatment
Atopic Dermatitis Drug: Pimecrolimus

Detailed Description:
Registry study to examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.
Study Design
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Study Type : Observational
Estimated Enrollment : 8000 participants
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)
Actual Study Start Date : June 27, 2005
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Groups and Cohorts
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Group/Cohort Intervention/treatment
1
Single-group Open Label Registry of patients exposed to Elidel/Pimecrolimus
 Drug: Pimecrolimus
Pimecrolimus 1% cream
Other Name: Elidel


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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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
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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): NCT00568997


Contacts
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Contact: Sandra Narain 908-242-8287 sandra.narain@bauschhealth.com

Locations
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United States, Pennsylvania
Registry Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: NA NA         
Sponsors and Collaborators
Bausch Health Americas, Inc.
Clinical Research Computing Unit (University of Pennsylvania)
Investigators
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Study Director: Anya Loncaric Bausch Health
More Information
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00568997    
Other Study ID Numbers: CASM981C2311
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: December 2021
Keywords provided by Bausch Health Americas, Inc.:
Atopic dermatitis eczema pediatric pimecrolimus malignancy
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
Pimecrolimus
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