This trial is active, not recruiting.

Condition atopic dermatitis
Sponsor LEO Pharma
Start date May 2005
End date August 2022
Trial size 8037 participants
Trial identifier NCT00475605, 03-0-161, F506-CL-5801, FG506-06-37


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Pediatric subjects whose ages are/were <16 years at the time of first tacrolimus ointment exposure

Primary Outcomes

The endpoint is the occurrence of serious adverse events, including the observation of systemic and cutaneous malignancies
time frame: At six month intervals for ten years

Eligibility Criteria

Male or female participants up to 16 years old.

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.

Additional Information

Official title APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by LEO Pharma.