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

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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.

Tracking Information
First Submitted Date December 5, 2007
First Posted Date December 6, 2007
Last Update Posted Date December 15, 2021
Actual Study Start Date June 27, 2005
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 2, 2011)		 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 ]
Original Primary Outcome Measures
 (submitted: December 5, 2007)		 Rate of lymphoma in pediatric subjects who have used pimecrolimus 1% cream.
Change History
Current Secondary Outcome Measures
 (submitted: September 2, 2011)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: December 5, 2007)
  • Rate of thyroid cancer in patients under study
  • Total number of systemic malignancies reported in study compared to those reported in National Institutes of Health (NIH) database
  • Investigation of dose response in the incidence of lymphoma
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus
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)
Brief Summary This study will examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.
Detailed Description Registry study to examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children (ages 2-17 years)
Condition Atopic Dermatitis
Intervention Drug: Pimecrolimus
Pimecrolimus 1% cream
Other Name: Elidel
Study Groups/Cohorts 1
Single-group Open Label Registry of patients exposed to Elidel/Pimecrolimus
Intervention: Drug: Pimecrolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 2, 2011)		 8000
Original Estimated Enrollment
 (submitted: December 5, 2007)		 4000
Estimated Study Completion Date December 2026
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Sandra Narain 908-242-8287 sandra.narain@bauschhealth.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00568997
Other Study ID Numbers CASM981C2311
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Bausch Health Americas, Inc.
Original Responsible Party Not Provided
Current Study Sponsor Bausch Health Americas, Inc.
Original Study Sponsor Novartis
Collaborators Clinical Research Computing Unit (University of Pennsylvania)
Investigators
Study Director: Anya Loncaric Bausch Health
PRS Account Bausch Health Americas, Inc.
Verification Date December 2021