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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

Study Description
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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 Design
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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

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Arms and Interventions
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Outcome Measures
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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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Contacts and Locations
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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
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Germany
Dep. Dermatology and Allergology, Ruhr-University Bochum
Bochum, Germany, 44791
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
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Principal Investigator: Peter Altmeyer, Prof. Dr. Ruhr University Bochum, Dep. Dermatology and Allergology
More Information
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ClinicalTrials.gov Identifier: NCT00350116    
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:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Vitamin B 12
Hydroxocobalamin
Vitamins
 Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex
Hematinics