NCT00350116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2001

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
Last Updated

July 10, 2006

Status Verified

July 1, 2006

First QC Date

July 6, 2006

Last Update Submit

July 6, 2006

Conditions

Chronic Plaque Psoriasis

Keywords

plaque psoriasisVitamin B12

Outcome Measures

Primary Outcomes (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.

Interventions

topical vitamin B12DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • chronic plaque psoriasis

You may not qualify if:

  • incapability of Vitamin B12
  • necessity of systemic therapy
  • use of other potentially psoriasis modifying drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. Dermatology and Allergology, Ruhr-University Bochum

Bochum, 44791, Germany

Location

MeSH Terms

Interventions

Vitamin B 12

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Peter Altmeyer, Prof. Dr.

    Ruhr University Bochum, Dep. Dermatology and Allergology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 10, 2006

Study Start

January 1, 2001

Study Completion

December 1, 2004

Last Updated

July 10, 2006

Record last verified: 2006-07

Locations

DE(1)