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, September 2009

First Received: May 17, 2007 Last Updated: September 16, 2009 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

Drug Information available for: Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

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
1. Protopic Exposure 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 368 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma Global Development

More Information

No publications provided

Responsible Party:	Astellas Pharma Global Development ( Sr Manager Clinical Trials Registry )
Study ID Numbers:	03-0-161, FG506-06-37
Study First Received:	May 17, 2007
Last Updated:	September 16, 2009
ClinicalTrials.gov Identifier:	NCT00475605 History of Changes
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency; Canada: Health Canada

Keywords provided by Astellas Pharma Inc:

Protopic Ointment
tacrolimus ointment
atopic dermatitis
child

Additional relevant MeSH terms:

Hypersensitivity
Dermatitis, Atopic
Immune System Diseases
Genetic Diseases, Inborn
Skin Diseases

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on November 30, 2009