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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00232115 |
An evaluation of the safety and efficacy of the calcineurin inhibitor, pimecrolimus cream 1%, in adult patients with perioral dermatitis.
This study is not enrolling patients in the United States.
Condition | Intervention | Phase |
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Perioral Dermatitis |
Drug: Pimecrolimus Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis |
Enrollment: | 124 |
Study Start Date: | September 2005 |
Study Completion Date: | July 2006 |
Arms | Assigned Interventions |
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1: Experimental
Pimecrolimus
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Drug: Pimecrolimus
Pimecrolimus cream 1 %
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2: Placebo Comparator
Vehicle
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Drug: Placebo
Vehicle cream (placebo)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Oral tetracyclines, oral erythromycin, oral steroids and oral calcineurin inhibitors. All topical treatments of the face, including steroids, calcineurin inhibitors, metronidazole, tetracyclines, erythromycin and emollients (exception: DAC Basiscreme).
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CASM981CDE15 |
Study First Received: | October 3, 2005 |
Last Updated: | January 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00232115 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Perioral Dermatitis, pimecrolimus cream |
Anti-Inflammatory Agents Facial Dermatoses Immunologic Factors Skin Diseases Facies Pimecrolimus Tacrolimus Immunosuppressive Agents |
Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Dermatitis Dermatitis, Perioral |
Anti-Inflammatory Agents Facial Dermatoses Immunologic Factors Skin Diseases Physiological Effects of Drugs Pimecrolimus Tacrolimus 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 Dermatitis Dermatitis, Perioral |