Open Label Study of Long Term Treatment of Pediatric Treatment of Atopic Dermatitis With Pimecrolimus Cream 1% Within a Usual Clinical Setting - Tabular View

Tracking Information

First Received Date ^ICMJE

July 31, 2007

Last Updated Date

February 13, 2008

Start Date ^ICMJE

April 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To evaluate the effectiveness of pimecrolimus cream 1% in the long-term management in mild to moderate atopic dermatitis in pediatric patients in a daily practice, as assessed by: • Investigator Global Assessment • Facial Investigator Global Ass

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00509990 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

• To monitor the safety of pimecrolimus cream 1% in the long-term management as assessed by Adverse Events and Serious Adverse Events collection • To evaluate quality of life of both parent and patient assessed by questionnaire. • To determine ste

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Open Label Study of Long Term Treatment of Pediatric Treatment of Atopic Dermatitis With Pimecrolimus Cream 1% Within a Usual Clinical Setting

Official Title ^ICMJE

Open Label Multicenter Study, 52 Weeks Duration, Using Pimecrolimus Cream 1% for the Long-Term Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Patients Within a Usual Clinical Setting

Brief Summary

An open-label, multicenter study, of long term management to evaluate effectiveness, tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate atopic dermatitis in a daily practice

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

Drug: Pimecrolimus

Study Arms / Comparison Groups

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

Completed

Estimated Enrollment ^ICMJE

200

Completion Date

September 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age ≥ 3 months to 12 years old
Clinical diagnosis of atopic dermatitis
History of mild to moderate atopic dermatitis
Investigator Global Assessment ≥ 1 (almost clear/clear of disease)
Written informed consent

Exclusion Criteria:

Investigator Global Assessment ≥ 4 (severe/very severe disease)
Patients with active skin viral infections (i.e, herpes simplex, herpes zoster, varicella)
Patients with atopic dermatitis, with active clinical infection on area of disease. All active infections must be treated prior to trial inclusion
Patients in an Immunosuppressive state or with history of malignant disease
Patients with clinical conditions other that Atopic Dermatitis that according to the investigator may interfere with the evaluation (i.e, Psoriasis, Netherton Syndrome)
Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

3 Months to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Mexico, Venezuela

Administrative Information

NCT ID ^ICMJE

NCT00509990

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CASM981CVE01

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Novartis

Novartis Pharma AG Basel, Switzerland

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