Topical Vitamin B12 in Chronic Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT00350116
First received: July 6, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose

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 Intervention Phase
Chronic Plaque Psoriasis
Drug: topical vitamin B12
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Topical Vitamin B12 in Chronic Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

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.

Estimated Enrollment: 48
Study Start Date: January 2001
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00350116     History of Changes
Other Study ID Numbers: 1-Stucker
Study First Received: July 6, 2006
Last Updated: July 6, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on August 25, 2014