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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014