Topical Vitamin B12 in Chronic Plaque Psoriasis

NCT ID: NCT00350116

Last Updated: 2006-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Plaque Psoriasis

Keywords

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plaque psoriasis Vitamin B12

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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topical vitamin B12

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18years
* chronic plaque psoriasis

Exclusion Criteria

* incapability of Vitamin B12
* necessity of systemic therapy
* use of other potentially psoriasis modifying drugs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Principal Investigators

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Peter Altmeyer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Ruhr University Bochum, Dep. Dermatology and Allergology

Locations

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Dep. Dermatology and Allergology, Ruhr-University Bochum

Bochum, , Germany

Site Status

Countries

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Germany

Other Identifiers

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1-Stucker

Identifier Type: -

Identifier Source: org_study_id