Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00351052

Purpose

This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic dermatitis

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Pimecrolimus Drug: Placebo	Phase III

Drug Information available for: Pimecrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 24-Week, Randomized, Multicenter, Parallel-Group, Double-Blind, Vehicle-Controlled Study on Pimecrolimus Cream 1% Assessing the Steroid-Sparing Effect in the Long Term Management of Pediatric Patients With Severe Atopic Dermatitis

Further study details as provided by Novartis:

Primary Outcome Measures:

Corticoid-sparing effect of pimecrolimus cream 1%

Secondary Outcome Measures:

atopic dermatitis control
safety of pimecrolimus cream 1%
quality of life

Enrollment:	184
Study Start Date:	December 2001
Study Completion Date:	September 2004

Arms	Assigned Interventions
1: Experimental Pimecrolimus	Drug: Pimecrolimus Pimecroliums cream 1 % bid.
2: Placebo Comparator Vehicle	Drug: Placebo Vehicle control (placebo) bid.

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Outpatients aged 2 to < 18 years with severe AD (score 8 or 9 according to Rajka and Langeland)
responded to 21 days of treatment with prednicarbate cream 0.25% during screening phase

Exclusion Criteria:

Patients who had received phototherapy, systemic or topical therapy or systemic corticosteroids shortly prior to study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351052

Locations

Germany

Investigational Site, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis AG

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CASM981CDE10
Study First Received:	July 10, 2006
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00351052
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Pimecrolimus, Atopic Dermatitis, Eczema, Pediatric

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate

Skin Diseases, Eczematous
Pimecrolimus
Eczema
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 14, 2009