Topical Vitamin B12 in Chronic Plaque Psoriasis

• Sponsor: Ruhr University of Bochum (Other)
• Overall Status: Completed
• CT.gov ID: NCT00350116
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Duration (Months): 47
• Patients Per Site Per Month: 1

Study Details

Study Description

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

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Topical Vitamin B12 in Chronic Plaque Psoriasis
• Study Start Date: Jan 1, 2001
• Study Completion Date: Dec 1, 2004

Outcome Measures

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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00350116
• Other Study ID Numbers: 1-Stucker
• First Posted: Jul 10, 2006
• Last Update Posted: Jul 10, 2006
• Last Verified: Jul 1, 2006

• Keywords provided by , ,: plaque psoriasis; Vitamin B12
• Additional relevant MeSH terms: Psoriasis; Vitamin B 12; Hydroxocobalamin

Study Results

No Results Posted as of Jul 10, 2006