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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Valeant Pharmaceuticals International, Inc.
Sponsor:
Collaborator:
Clinical Research Computing Unit (University of Pennsylvania)
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00568997
First received: December 5, 2007
Last updated: March 12, 2013
Last verified: March 2013
  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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8000
Study Start Date: June 2004
Estimated Study Completion Date: December 2021
Groups/Cohorts Assigned Interventions
1
Single-group
Drug: Pimecrolimus
Pimecrolimus 1% cream
Other Name: Elidel

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00568997

Contacts
Contact: Valeant Pharmaceuticals 908-927-1400

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

Additional Information:
No publications provided

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00568997     History of Changes
Other Study ID Numbers: CASM981C2311
Study First Received: December 5, 2007
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Pimecrolimus
Tacrolimus
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014