Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification
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|ClinicalTrials.gov Identifier: NCT00124709|
Recruitment Status : Terminated
First Posted : July 28, 2005
Results First Posted : March 23, 2011
Last Update Posted : March 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Pimecrolimus Drug: Corticosteroid||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1091 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Primary Completion Date :||January 2008|
|Study Completion Date :||November 2008|
Pimecrolimus cream 1 %
Other Name: Elidel
Active Comparator: 2
conventional corticosteroid-based treatment
- 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.
- 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.
- 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.
- 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.
- 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.
- 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".
- 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.
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): NCT00124709
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|Study Chair:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|