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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00351052
Recruitment Status : Completed
First Posted : July 12, 2006
Last Update Posted : January 17, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic dermatitis

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Pimecrolimus Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
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
Study Start Date : December 2001
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Pimecrolimus
Drug: Pimecrolimus
Pimecroliums cream 1 % bid.
Other Name: Elidel
Placebo Comparator: 2
Vehicle
Drug: Placebo
Vehicle control (placebo) bid.


Outcome Measures

Primary Outcome Measures :
  1. Corticoid-sparing effect of pimecrolimus cream 1%

Secondary Outcome Measures :
  1. atopic dermatitis control
  2. safety of pimecrolimus cream 1%
  3. quality of life

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351052


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

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00351052     History of Changes
Other Study ID Numbers: CASM981CDE10
First Posted: July 12, 2006    Key Record Dates
Last Update Posted: January 17, 2008
Last Verified: January 2008

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
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
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action