Safety and Efficacy Study of Bimosiamose Cream to Treat P... | NCT00823693

Studies
Safety and Efficacy Study of Bimosiamose Cream to Treat Psoriasis

NCT00823693

Sponsor

Revotar Biopharmaceuticals AG

Status

Completed

Last Update Posted

Aug 21, 2009Estimated

Enrollment

107Actual

Phase

Phase 2

Conditions

Psoriasis

Interventions

Bimosiamose Cream
Placebo Cream

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 14, 2009

First Submission Date that Met QC Criteria

Jan 15, 2009

First Posted Date

Jan 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2009

Last Update Posted Date

Aug 21, 2009Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

107Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bimosiamose Cream	Active Comparator		Drug: Bimosiamose Cream
Placebo Cream	Placebo Comparator		Drug: Placebo Cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bimosiamose Cream	Drug		Bimosiamose Cream
Placebo Cream

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité Campus Mitte, Klinik für Dermatologie, Venerologie und Allergologie		Berlin			Germany

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided