Safety and Efficacy Study of Bimosiamose Cream to Treat Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823693
• Other study ID #: R013
• Status: Completed
• Phase: Phase 2
• First received: January 14, 2009
• Last updated: August 20, 2009

Study information

• Verified date: August 2009
• Source: Revotar Biopharmaceuticals AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Bimosiamose Cream

• Placebo Cream

Locations

Country	Name	City	State
Germany	Charité Campus Mitte, Klinik für Dermatologie, Venerologie und Allergologie	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Revotar Biopharmaceuticals AG

Country where clinical trial is conducted

Germany,