Study title:
Phase 3, randomized, double-blind, multi-center, vehicle-controlled, parallel, two-treatment group study stratified by baseline PSGA and investigative site to evaluate the efficacy and safety of tacrolimus cream 0.03% applied twice daily (bid) compared to cream vehicle applied bid for the treatment of atopic dermatitis.
Type of medicine: Centrally authorised medicines
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Therapeutic area: Skin and Connective Tissue Diseases
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Brands: Please see report |
MAH holders: Please see report |
Assessment: |
Active substance: Tacrolimus |
ATC code: D11AX14 |
Document link:
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Document date: 2011-11-10
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Study number: 03-0-166
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EudraCT number:
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Scope of study: CLINICAL |
Population of study subjects:
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Preterm newborn Infants
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Newborn infants
(1 to 27 days)
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Infants and toddlers
(28 days to 24 months)
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Children
(2 to 11 years)
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Adolescents
(12 to 18 years)
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-
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-
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Y
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Y
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Y
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