Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00351052
First received: July 10, 2006
Last updated: January 15, 2008
Last verified: January 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Experimental: 1
Pimecrolimus
Drug: Pimecrolimus
Pimecroliums cream 1 % bid.
Other Name: Elidel
Placebo Comparator: 2
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

No publications provided

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

Keywords provided by Novartis:
Pimecrolimus, Atopic Dermatitis, Eczema, Pediatric

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 April 17, 2014