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

Bausch Health

Status: Active, not recruiting

Conditions: Atopic Dermatitis

Treatments: Drug: Pimecrolimus

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00568997

CASM981C2311

Details and patient eligibility

About

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

Full description

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

Enrollment: 8,000 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

8,000 participants in 1 patient group

1

Description:

Single-group Open Label Registry of patients exposed to Elidel/Pimecrolimus

Treatment:

Drug: Pimecrolimus