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

Last updated: February 22, 2024
Sponsor: Bausch Health Americas, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hives (Urticaria)

Allergies & Asthma

Skin Infections/disorders

Treatment

Pimecrolimus

Clinical Study ID

NCT00568997
CASM981C2311
  • Ages 2-17
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • past or present history of systemic malignancy, skin malignancy, orlymphoproliferative disease
  • past or present use of oral immunosuppressive therapy

Study Design

Total Participants: 8000
Treatment Group(s): 1
Primary Treatment: Pimecrolimus
Phase:
Study Start date:
June 27, 2005
Estimated Completion Date:
December 31, 2026

Study Description

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

Connect with a study center

  • Registry

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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