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

This study has been completed.

First Received: July 31, 2007 Last Updated: February 13, 2008 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00509990

Purpose

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

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Pimecrolimus	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Pimecrolimus

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

• 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

Estimated Enrollment:	200
Study Start Date:	April 2005
Study Completion Date:	September 2007

Intervention Details:

Pimecrolimus cream 1 %

Eligibility

Ages Eligible for Study:	3 Months to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509990

Locations

Mexico
Novartis Investigative Site
Puebla, Mexico
Novartis Investigative Site
Monterrey, Mexico
Novartis Investigative Site
Mexico, Mexico
Venezuela
Novartis Investigative Site, Edo
Carabobo, Venezuela
Novartis Investigative Site
Caracas, Venezuela
Novartis Investigative Site
Aragua, Venezuela

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

Novartis Pharma AG Basel, Switzerland

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CASM981CVE01
Study First Received:	July 31, 2007
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00509990 History of Changes
Health Authority:	Mexico: Secretaría de Salud, Estados Unidos Mexicanos; Venezuela: Instituto Nacional de Higiene "Rafael Rangel", Ministerio de Salud, Republica Bolivariana de Venezuela

Keywords provided by Novartis:

Atopic dermatitis, pimecrolimus, children

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dermatitis, Atopic
Immunologic Factors
Physiological Effects of Drugs
Tacrolimus
Hypersensitivity
Sensory System Agents
Therapeutic Uses
Skin Diseases, Eczematous
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Skin Diseases, Genetic
Dermatologic Agents

Dermatitis
Immune System Diseases
Skin Diseases
Pimecrolimus
Immunosuppressive Agents
Pharmacologic Actions
Genetic Diseases, Inborn
Analgesics, Non-Narcotic
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009