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| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00139581 |
Purpose
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.
|
Drug: Pimecrolimus
Pimecrolimus cream 1 % applied twice daily (b.i.d.)
|
|
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.)
|
Eligibility| 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
Contacts and Locations
More Information
| Responsible Party: | Novartis ( External Affairs ) |
| Study ID Numbers: | CASM981C2314 |
| Study First Received: | August 30, 2005 |
| Last Updated: | April 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00139581 History of Changes |
| 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 |
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Atopic dermatitis, children, infants, pimecrolimus, bid, od |
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Anti-Inflammatory Agents Dermatitis, Atopic Immunologic Factors Physiological Effects of Drugs Tacrolimus Hypersensitivity Sensory System Agents Therapeutic Uses Skin Diseases, Eczematous Anti-Inflammatory Agents, Non-Steroidal Analgesics Skin Diseases, Genetic Dermatologic Agents |
Dermatitis Immune System Diseases Skin Diseases Pimecrolimus Immunosuppressive Agents Pharmacologic Actions Genetic Diseases, Inborn Analgesics, Non-Narcotic Hypersensitivity, Immediate Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |