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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00139581 |
This study is not being conducted in the United States.
To investigate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.) versus once daily (o.d.) in preventing the progression to disease "relapse".
Condition | Intervention | Phase |
---|---|---|
Atopic Dermatitis |
Drug: Pimecrolimus |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects |
Study Start Date: | September 2004 |
Study Completion Date: | September 2005 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Pimecrolimus b.i.d.
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Drug: Pimecrolimus
Pimecrolimus cream 1 % applied twice daily (b.i.d.)
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2: Experimental
Pimecrolimus o.d. and placebo o.d.
|
Drug: Pimecrolimus
Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.)
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Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria - Screening/Run-In Period
Exclusion Criteria:Screening/Run-In period
Inclusion criteria - Double-blind Maintenance treatment period
- Achieve complete remission of active disease (no signs or symptoms of AD) without incidence of "relapse" by the end of 6-week Run-In period (may be earlier); or who achieve "disease improvement" (decrease in IGA score by 1 full point confirmed by the investigator) without incidence of relapse at the end of the 6-week Run-In period
Exclusion criteria - Double-blind Maintenance treatment period
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CASM981C2314 |
Study First Received: | August 30, 2005 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00139581 |
Health Authority: | Austria: Federal Ministry for Health and Women; Belgium: Directorate general for the protection of Public health: Medicines; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Spain: Spanish Agency of Medicines; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Atopic dermatitis, children, infants, pimecrolimus, bid, od |
Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases Hypersensitivity, Immediate |
Skin Diseases, Eczematous Pimecrolimus Tacrolimus Skin Diseases, Genetic Dermatitis |
Anti-Inflammatory Agents Immunologic Factors Immune System Diseases Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic Sensory System Agents |
Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Dermatologic Agents |