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


Bausch Health Americas, Inc.
NCT ID: NCT00568997
Last Updated: November 21, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase:
  • Gender: All
  • Age: 2 Years - 17 Years
  • Condition: Atopic Dermatitis
  • Study Type: Observational
  • Intervention:
  • Lead Sponsor: Bausch Health Americas, Inc.
  • Location: Not Provided

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)

Purpose

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

Eligibility

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Additional Information, Locations & Contacts

Sponsors & Collaborators

Bausch Health Americas, Inc.

Clinical Research Computing Unit (University of Pennsylvania)

Investigators

Not Provided

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568997

Location

Contacts

Registry

Philadelphia, Pennsylvania 19104

United States

NA NA