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

This study has been terminated.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00124709
First received: July 26, 2005
Last updated: February 25, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Atopic Dermatitis
Drug: Pimecrolimus
Drug: Corticosteroid
Phase 4

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: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Atopic Dermatitis (AD) Disease Control Over 36 Months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.

  • Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Note: The results for this efficacy variable are not reported due to early termination of the study.


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

  • Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies [ Time Frame: 6 years (36 month Double-Blind Phase) ] [ Designated as safety issue: No ]

    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.


  • Corticosteroid and Pimecrolimus Drug Use [ Time Frame: 48 months ] [ Designated as safety issue: No ]

    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.


  • Atopic Dermatitis (AD) Remission Time [ Time Frame: 36 month Double-Blind Phase ] [ Designated as safety issue: No ]
    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".

  • Patient/Caregiver Quality of Life [ Time Frame: From Baseline to Visit 5 , 6, 8, 10, 12, and 14 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1091
Study Start Date: October 2003
Study Completion Date: November 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pimecrolimus
Drug: Pimecrolimus
Pimecrolimus cream 1 %
Other Name: Elidel
Active Comparator: 2
Corticosteroid
Drug: Corticosteroid
conventional corticosteroid-based treatment

  Eligibility

Ages Eligible for Study:   3 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  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: NCT00124709

  Show 36 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00124709     History of Changes
Other Study ID Numbers: CASM981CUS09
Study First Received: July 26, 2005
Results First Received: December 8, 2010
Last Updated: February 25, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Pimecrolimus
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014