A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis (APPLES)

LEO Pharma

Status: Terminated

Conditions: Atopic Dermatitis

Study type: Observational

Funder types: Industry

Identifiers

NCT00475605

FG506-06-37 (Other Identifier)

EUPAS (Registry Identifier)

F506-CL-5801

03-0-161 (Other Identifier)

LP0156-1294 (Other Identifier)

Details and patient eligibility

About

This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.

Full description

Data will be collected at enrollment and every 6 months thereafter either by interview, Internet, or physician office visit. Each subject will be followed for 10 years in this study.

Enrollment: 8,071 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects who first used Protopic® 0.03% or 0.1% before they were sixteen years of age and were treated for at least 6 weeks for the treatment of Atopic dermatitis may enroll into the study.

Trial design

8,071 participants in 1 patient group

1. Protopic Exposure

Description:

Pediatric subjects whose ages are/were \<16 years at the time of first tacrolimus ointment exposure