Safety and Efficacy Study of Bimosiamose Cream to Treat Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Revotar Biopharmaceuticals AG
ClinicalTrials.gov Identifier:
NCT00823693
First received: January 14, 2009
Last updated: August 20, 2009
Last verified: August 2009
  Purpose

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


Condition Intervention Phase
Psoriasis
Drug: Bimosiamose Cream
Drug: Placebo Cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 NLM:


Further study details as provided by Revotar Biopharmaceuticals AG:

Enrollment: 107
Arms Assigned Interventions
Active Comparator: Bimosiamose Cream Drug: Bimosiamose Cream
Placebo Comparator: Placebo Cream Drug: Placebo Cream

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823693

Locations
Germany
Charité Campus Mitte, Klinik für Dermatologie, Venerologie und Allergologie
Berlin, Germany
Sponsors and Collaborators
Revotar Biopharmaceuticals AG
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00823693     History of Changes
Other Study ID Numbers: R013
Study First Received: January 14, 2009
Last Updated: August 20, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 22, 2014