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

APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00475605

Acronym

APPLES

Enrollment

8071

Registered

2007-05-21

Start date

2005-05-25

Completion date

2019-01-31

Last updated

2019-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis, child, tacrolimus ointment, Protopic Ointment

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 16 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Occurrence of systemic or cutaneous malignancy	10 years	Standardised Incidence Ratio (versus population cancer rates)

Countries

Austria, Canada, France, Germany, Ireland, Netherlands, Poland, United Kingdom, United States

Outcome results