Text Size

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:

U.S. FDA Resources

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
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 May 23, 2013