Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification

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. Identifier: NCT00124709
Recruitment Status : Terminated
First Posted : July 28, 2005
Results First Posted : March 23, 2011
Last Update Posted : March 23, 2011
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Brief Summary:
This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Pimecrolimus Drug: Corticosteroid Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1091 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Investigation of the Safety and Efficacy of Elidel® 1% Cream in Atopic Disease Modification, Assessed in a 3-year Randomized Double-blind Vehicle Controlled Phase to Evaluate Effects on Atopic Dermatitis in Infants, and a 2-3 Year Open-label Phase to Evaluate the Effect of Early Intervention Versus Delayed Intervention With Elidel® on the Incidence of Asthma in Children
Study Start Date : October 2003
Actual Primary Completion Date : January 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Eczema Steroids
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: Pimecrolimus
Pimecrolimus cream 1 %
Other Name: Elidel
Active Comparator: 2
Drug: Corticosteroid
conventional corticosteroid-based treatment

Primary Outcome Measures :
  1. Atopic Dermatitis (AD) Disease Control Over 36 Months [ Time Frame: 36 months ]
    Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.

  2. Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age [ Time Frame: 6 years ]
    Note: The results for this efficacy variable are not reported due to early termination of the study.

Secondary Outcome Measures :
  1. Long Term Safety in Infants and Young Children [ Time Frame: 6 years ]
    Note: The results of this secondary outcome is not reported due to early termination of the study.

  2. Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies [ Time Frame: 6 years (36 month Double-Blind Phase) ]

    Percentage of Patients who had allergic rhinitis, allergic conjunctivitis and food allergies at the end of the 36 month double blind study.

    Note: The results at six years are not reported due to early termination of the study.

  3. Corticosteroid and Pimecrolimus Drug Use [ Time Frame: 48 months ]

    Corticosteroid and pimecrolimus study medication days of exposure during the 36 month double-blind phase.

    Note: Although the double-blind phase was designed to be 36 months (3 years) in length, the last double-blind visit for some patients occurred after 36 months.

  4. Atopic Dermatitis (AD) Remission Time [ Time Frame: 36 month Double-Blind Phase ]
    Longest duration of atopic dermatitis (AD) remission during the 36 month double-blind treatment phase. A remission day was defined as a diary day with a positive response ("yes") to the question "No or almost no eczema?" and a response of no treatment except emollients to the question "Medication used".

  5. Patient/Caregiver Quality of Life [ Time Frame: From Baseline to Visit 5 , 6, 8, 10, 12, and 14 ]
    Change from Baseline in the total Parents' Index of Quality of Life-Atopic Dermatitis (PIQoL-AD) score in the double-blind phase. PIQoL-AD Score = (sum of valid items/number of valid items) * 28. Scores range from a minimum value of 0 to a maximum value of 28 with a high total overall score indicating poor quality of life.

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Ages Eligible for Study:   3 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of atopic dermatitis
  • Family history of atopy
  • 3 to 18 months of age at baseline
  • At least mild atopic dermatitis at baseline (investigator global assessment [IGA] greater or equal to 2)
  • Clinical evidence of atopic dermatitis for no longer than 3 months

Exclusion Criteria:

  • Diagnosis of or substantial clinical evidence for food or other allergies at baseline

Other protocol related criteria may apply

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 identifier (NCT number): NCT00124709

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Sponsors and Collaborators
Novartis Pharmaceuticals
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00124709     History of Changes
Other Study ID Numbers: CASM981CUS09
First Posted: July 28, 2005    Key Record Dates
Results First Posted: March 23, 2011
Last Update Posted: March 23, 2011
Last Verified: February 2011

Keywords provided by Novartis:
Atopic, dermatitis, asthma, children, modification
Atopic dermatitis/atopy

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