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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Atopic
Dermatitis
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
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 September 16, 2014