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 on July 31, 2007. Last Updated on November 1, 2011 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Pimecrolimus cream 1 %

Other Name: Elidel

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

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Chair:

Novartis

Novartis Pharma AG Basel, Switzerland

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00509990 History of Changes
Other Study ID Numbers:	CASM981CVE01
Study First Received:	July 31, 2007
Last Updated:	November 1, 2011
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:

Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012