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

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Collaborator: Clinical Research Computing Unit (University of Pennsylvania)
• Treatments: Pimecrolimus; Tacrolimus

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