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NCT00350116 Clinical Trial

Topical Vitamin B12 in Chronic Plaque Psoriasis

Chronic Plaque Psoriasis Clinical Trial

Official title:
Topical Vitamin B12 in Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00350116
Other study ID # 1-Stucker
Secondary ID
Status Completed
Phase Phase 3
First received July 6, 2006
Last updated July 6, 2006
Start date January 2001
Est. completion date December 2004

Study information
Verified date July 2006
Source Ruhr University of Bochum
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18years

- chronic plaque psoriasis

Exclusion Criteria:

- incapability of Vitamin B12

- necessity of systemic therapy

- use of other potentially psoriasis modifying drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• topical vitamin B12

Locations
Country Name City State
Germany Dep. Dermatology and Allergology, Ruhr-University Bochum Bochum

Sponsors (1)
Lead Sponsor Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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