A Quality of Life and Safety Study With Pimecrolimus Cream, 1% in Children (Age 2-12 Years) With Atopic Dermatitis

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00484003

First received: June 7, 2007

Last updated: February 13, 2008

Last verified: February 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

June 7, 2007

Last Updated Date

February 13, 2008

Start Date ^ICMJE

October 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Quality of Life assessment on scheduled visits at Day 1 (Baseline), Day 14 and Day 90 or day of early discontinuation visit.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00484003 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety data will be collected by monitoring and recording all adverse events (AEs)and Serious Adverse Events(SAEs) throughout the duration of the trial.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Quality of Life and Safety Study With Pimecrolimus Cream, 1% in Children (Age 2-12 Years) With Atopic Dermatitis

Official Title ^ICMJE

A 3-Month Open Label, National, Quality of Life , and Safety Study With Pimecrolimus Cream, 1% in Children (Age 2-12 Years ) With Atopic Dermatitis

Brief Summary

The study will evaluate the safety and effect of pimecrolimus cream 1% on quality of life of caregivers of South African children with mild to moderate atopic dermatitis (AD).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Atopic Eczema

Intervention ^ICMJE

Drug: Pimecrolimus cream 1%

Other Name: Elidel

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

December 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female
Age ≥2 years ≤12 years of age
Atopic dermatitis on sensitive skin areas only ( i.e. face , neck and flexures )
Subjects in whom other treatment modalities are inadvisable according to the investigator's clinical opinion or have failed on other treatment modalities due to intolerance or inadequate response.
Patients with a history of mild to moderate AD
Subjects should present at visit 1 with a clear clinical diagnosis of mild to moderate AD.
Subject's parents or legal guardian must have been informed of the study procedures and must have signed the Informed Consent form approved for the study prior to any study related procedures

Exclusion Criteria:

Subjects who have active viral infections at the site(s) of treatment. In the presence of other dermatological infections, the use of appropriate antimicrobial agents should be instituted.
Subjects who present with systemic malignancy or active lymphoproliferative diseases/disorders (e.g., lymphoma, neoplastic disease, chronic lymphoproliferation).
Subjects who present with clinical conditions other than AD that can, in the opinion of the investigator, interfere with the evaluation
Subjects who are receiving photo-therapy (e.g., PUVA, UVB) or immunosuppressive therapy (e.g., cyclosporine, FK-506 [tacrolimus]).
Subjects who have used investigational drugs within 8 weeks prior to first application of study medication or intended use of other investigational drugs during the course of this study.
Subjects who have used, or are using 0.03% or 0.1% tacrolimus ointment.
Pimecrolimus cream 1% is contraindicated in subjects who have known or suspected hypersensitivity to pimecrolimus or any components of the cream
Subjects not medically stable or subjects with any condition which, in the opinion of the investigator, should render the subject ineligible for the study.
Pregnancy and lactation (if applicable)
Pimecrolimus cream 1% should not be used during pregnancy or lactation

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

2 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

South Africa

Administrative Information

NCT Number ^ICMJE

NCT00484003

Other Study ID Numbers ^ICMJE

CASM981CZA01

Has Data Monitoring Committee

Not Provided

Responsible Party

External Affairs, Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

February 2008

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

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