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| Sponsored by: |
Dresden University of Technology |
|---|---|
| Information provided by: | Dresden University of Technology |
| ClinicalTrials.gov Identifier: | NCT00148746 |
Purpose
The study was designed to test the hypothesis whether a standardized, time-and score-oriented treatment following a strict evidence based algorithm is equally effective to a standard treatment regimen for moderate to severe atopic dermatitis.
Study Type: Mono-centre study, patients are blinded, physicians are randomized to either treat study- or controll group
Eligible are patients age 2 years or older with SCORAD >= 20 Duration: 12 Months, study visits every 4 weeks.
Primary endpoint is Difference between Baseline SCORAD and mean SCORAD under treatment.
Secundary endpoints are quality of life, safety and economic burden in both treatment groups.
| Condition | Intervention |
|---|---|
|
Moderate to Severe Atopic Dermatitis |
Drug: Pimecrolimus Drug: Tacrolimus Drug: Prednisolone Drug: Ciclosporin A Drug: Dermatop |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Standardized Time- and Score-Oriented Treatment of Moderate and Severe Atopic Dermatitis |
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Department of Dermatology, TU Dresden | |
| Dresden, Germany, 01307 | |
| Study Director: | Jochen M Schmitt, MD, MPH | Dpt. of Dermatology, Medical Faculty, Technical University Dresden, Germany |
More Information
| Study ID Numbers: | DERMA_AD_001 |
| Study First Received: | September 6, 2005 |
| Last Updated: | June 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00148746 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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atopic dermatitis, atopy |
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Anti-Inflammatory Agents Cyclosporine Dermatitis, Atopic Immunologic Factors Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Prednisolone acetate Tacrolimus Cyclosporins Hormones Hypersensitivity Antifungal Agents Skin Diseases, Eczematous Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Skin Diseases, Genetic Dermatitis Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Skin Diseases Methylprednisolone acetate Pimecrolimus Immunosuppressive Agents Glucocorticoids Genetic Diseases, Inborn Analgesics, Non-Narcotic Prednisolone Hypersensitivity, Immediate Peripheral Nervous System Agents |
|
Anti-Inflammatory Agents Anti-Infective Agents Cyclosporine Dermatitis, Atopic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Tacrolimus Hormones Cyclosporins Hypersensitivity Sensory System Agents Antifungal Agents |
Therapeutic Uses Skin Diseases, Eczematous Anti-Inflammatory Agents, Non-Steroidal Analgesics Skin Diseases, Genetic Dermatologic Agents Dermatitis Antineoplastic Agents, Hormonal Immune System Diseases Skin Diseases Pimecrolimus Enzyme Inhibitors Glucocorticoids Immunosuppressive Agents Pharmacologic Actions |
