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

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

This study is currently recruiting participants.
Verified by Astellas Pharma Inc, July 2008

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00475605

Purpose

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.

Condition

Atopic Dermatitis

ChemIDplus related topics:

Tacrolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	8000
Study Start Date:	May 2005
Estimated Study Completion Date:	December 2023
Estimated Primary Completion Date:	December 2023 (Final data collection date for primary outcome measure)

Groups/Cohorts

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

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.

Eligibility

Ages Eligible for Study:	up to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475605

Contacts


Contact: APPLES Study Line	(877) 277-7530	clintrials.info@us.astellas.com

Show 329 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Study Director:	Use Central Contact	Astellas Pharma US, Inc.

More Information

Responsible Party:	Astellas Pharma US, Inc ( Sr Manager Clinical Trials Registry )
Study ID Numbers:	03-0-161, FG506-06-37
First Received:	May 17, 2007
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00475605
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency

Keywords provided by Astellas Pharma Inc:

Protopic Ointment

tacrolimus ointment

atopic dermatitis

child

Study placed in the following topic categories:

Hypersensitivity

Dermatitis, Atopic

Genetic Diseases, Inborn

Skin Diseases

Hypersensitivity, Immediate

Skin Diseases, Eczematous

Tacrolimus

Skin Diseases, Genetic

Dermatitis

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on September 04, 2008