Back to resultsTopical Vitamin B12 in Chronic Plaque Psoriasis
Primary Purpose
Chronic Plaque Psoriasis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
topical vitamin B12
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring plaque psoriasis, Vitamin B12
Eligibility Criteria
Inclusion Criteria: 18years chronic plaque psoriasis Exclusion Criteria: incapability of Vitamin B12 necessity of systemic therapy use of other potentially psoriasis modifying drugs
Sites / Locations
- Dep. Dermatology and Allergology, Ruhr-University Bochum
Outcomes
Primary Outcome Measures
Main outcome measures: Modified Psoriasis Area and Severity Index (PASI) at weeks 0, 2, 4, 6 and 8. Thickness and density of 3 references plaques determined by 20 MHz sonography. Assessment of efficiency and tolerability by patients and investigators.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00350116
Brief Title
Topical Vitamin B12 in Chronic Plaque Psoriasis
Official Title
Topical Vitamin B12 in Chronic Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ruhr University of Bochum
4. Oversight
5. Study Description
Brief Summary
Objective: To test the efficacy and tolerability of a vitamin B12 cream for the treatment of chronic plaque psoriasis.
Design: Multicenter, double-blind, randomized, placebo-controlled trial.
Detailed Description
Objective: To test the efficacy and tolerability of a vitamin B12 cream for the treatment of chronic plaque psoriasis.
Design: Multicenter, double-blind, randomized, placebo-controlled trial. Setting: ambulatory patients in research or referral centers. Patients: Volunteer sample of 51 patients with chronic plaque psoriasis. Interventions: All Patients applied vitamin B12 cream twice daily for 8 weeks to one side of the body and placebo to the other.
Main outcome measures: Modified Psoriasis Area and Severity Index (PASI) at weeks 0, 2, 4, 6 and 8. Thickness and density of 3 references plaques determined by 20 MHz sonography. Assessment of efficiency and tolerability by patients and investigators.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
Keywords
plaque psoriasis, Vitamin B12
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
48 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
topical vitamin B12
Primary Outcome Measure Information:
Title
Main outcome measures: Modified Psoriasis Area and Severity Index (PASI) at weeks 0, 2, 4, 6 and 8. Thickness and density of 3 references plaques determined by 20 MHz sonography. Assessment of efficiency and tolerability by patients and investigators.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18years
chronic plaque psoriasis
Exclusion Criteria:
incapability of Vitamin B12
necessity of systemic therapy
use of other potentially psoriasis modifying drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Altmeyer, Prof. Dr.
Organizational Affiliation
Ruhr University Bochum, Dep. Dermatology and Allergology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. Dermatology and Allergology, Ruhr-University Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Topical Vitamin B12 in Chronic Plaque Psoriasis
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