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Topical Vitamin B12 in Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT00350116
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : July 10, 2006
Sponsor:
Information provided by:
Ruhr University of Bochum

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.


Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: topical vitamin B12 Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Topical Vitamin B12 in Chronic Plaque Psoriasis
Study Start Date : January 2001
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18years
  • chronic plaque psoriasis

Exclusion Criteria:

  • incapability of Vitamin B12
  • necessity of systemic therapy
  • use of other potentially psoriasis modifying drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350116


Locations
Germany
Dep. Dermatology and Allergology, Ruhr-University Bochum
Bochum, Germany, 44791
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: Peter Altmeyer, Prof. Dr. Ruhr University Bochum, Dep. Dermatology and Allergology

ClinicalTrials.gov Identifier: NCT00350116     History of Changes
Other Study ID Numbers: 1-Stucker
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: July 10, 2006
Last Verified: July 2006

Keywords provided by Ruhr University of Bochum:
plaque psoriasis
Vitamin B12

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics