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Safety and Efficacy Study of Bimosiamose Cream to Treat Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00823693
Recruitment Status : Completed
First Posted : January 16, 2009
Last Update Posted : August 21, 2009
Sponsor:
Information provided by:
Revotar Biopharmaceuticals AG

Study Description
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Brief Summary:
The purpose of this study is to determine whether Bimosiamose Cream is safe and effective in the treatment of plaque type psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Bimosiamose Cream Drug: Placebo Cream Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety and Efficacy of Bimosiamose 5% Cream for the Treatment of Patients With Chronic Plaque Type Psoriasis

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bimosiamose Cream Drug: Bimosiamose Cream
Placebo Comparator: Placebo Cream Drug: Placebo Cream


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of plaque type psoriasis PASI score of 5-15
  • At least 18 years of age
  • Written informed consent

Exclusion Criteria:

  • Active skin infection
  • More than 20% Body Surface Area (BSA) affected by psoriasis
  • Use of certain anti-psoriasis medication or treatments
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823693


Locations
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Germany
Charité Campus Mitte, Klinik für Dermatologie, Venerologie und Allergologie
Berlin, Germany
Sponsors and Collaborators
Revotar Biopharmaceuticals AG
More Information
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ClinicalTrials.gov Identifier: NCT00823693    
Other Study ID Numbers: R013
First Posted: January 16, 2009    Key Record Dates
Last Update Posted: August 21, 2009
Last Verified: August 2009
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases