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Safety and Efficacy Study of Bimosiamose Cream to Treat Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Bimosiamose Cream
Placebo Cream
Sponsored by
Revotar Biopharmaceuticals AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Campus Mitte, Klinik für Dermatologie, Venerologie und Allergologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bimosiamose Cream

Placebo Cream

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 14, 2009
Last Updated
August 20, 2009
Sponsor
Revotar Biopharmaceuticals AG
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1. Study Identification

Unique Protocol Identification Number
NCT00823693
Brief Title
Safety and Efficacy Study of Bimosiamose Cream to Treat Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Revotar Biopharmaceuticals AG

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bimosiamose Cream
Arm Type
Active Comparator
Arm Title
Placebo Cream
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bimosiamose Cream
Intervention Type
Drug
Intervention Name(s)
Placebo Cream

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Charité Campus Mitte, Klinik für Dermatologie, Venerologie und Allergologie
City
Berlin
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Bimosiamose Cream to Treat Psoriasis

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