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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: July 10, 2006
Last updated: January 15, 2008
Last verified: January 2008
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Drug: Pimecrolimus
Pimecroliums cream 1 % bid.
Other Name: Elidel
Placebo Comparator: 2
Drug: Placebo
Vehicle control (placebo) bid.


Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All

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
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Please refer to this study by its identifier: NCT00351052

Investigational Site, Germany
Sponsors and Collaborators
Study Chair: Novartis AG Novartis
  More Information

Responsible Party: External Affairs, Novartis Identifier: NCT00351052     History of Changes
Other Study ID Numbers: CASM981CDE10
Study First Received: July 10, 2006
Last Updated: January 15, 2008

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

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 20, 2017