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

Tracking Information

First Received Date ^ICMJE

December 5, 2007

Last Updated Date

November 2, 2009

Start Date ^ICMJE

June 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Rate of lymphoma in pediatric subjects who have used pimecrolimus 1% cream.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00568997 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rate of thyroid cancer in patients under study
Total number of systemic malignancies reported in study compared to those reported in SEER (Surveillance Epidemiology and End Results) database
Investigation of dose response in the incidence of lymphoma

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Prospective 10 Year Observational Registry of Pediatric Subjects (Age Greater Than or Equal to Two to Age Less Than or Equal to 17 Years) With Atopic Dermatitis Who Have Used Pimecrolimus 1% Cream

Brief Summary

This study will examine the incidence of lymphoma in pediatric subjects who have been exposed to pimecrolimus 1% cream.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

Drug: Pimecrolimus

Study Arms / Comparison Groups

Single-group

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

4000

Estimated Completion Date

April 2018

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

2 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Novartis Pharma

862-778-8300

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00568997

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CASM981C2311

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Clinical Research Computing Unit (University of Pennsylvania)

Investigators ^ICMJE

Information Provided By

Novartis

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP