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

Tracking Information

First Received Date ^ICMJE

May 17, 2007

Last Updated Date

September 16, 2009

Start Date ^ICMJE

May 2005

Estimated Primary Completion Date

December 2023 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00475605 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

8000

Estimated Completion Date

December 2023

Estimated Primary Completion Date

December 2023 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

up to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: APPLES Study Line

(877) 277-7530

clintrials.info@us.astellas.com

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00475605

Responsible Party

Sr Manager Clinical Trials Registry, Astellas Pharma Global Development

Study ID Numbers ^ICMJE

03-0-161, FG506-06-37

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Use Central Contact

Astellas Pharma Global Development

Information Provided By

Astellas Pharma Inc

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP