NCT00465699

Brief Summary

This study is being done to see in B12 applied to the skin will improve the symptoms of eczema in children compared to a placebo creme

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
Last Updated

April 25, 2007

Status Verified

April 1, 2007

First QC Date

April 23, 2007

Last Update Submit

April 23, 2007

Conditions

Eczema

Keywords

EczemaPediatricVitamin B12

Outcome Measures

Primary Outcomes (1)

  • Reduction in SCORAD at 2 and 4 weeks

Interventions

Topical B12 0.07%DRUG

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children presenting to the Center for Family Medicine or Regional Pediatrics between the ages of 6 months and 18 years old with atopic dermatitis

You may not qualify if:

  • unwillingness of parent to consent to study protocol, pregnancy or lactation, eczema with superinfection present, known history of allergy to Vitamin B12 or components of the base cream, topical treatment with corticosteroids in the 4 weeks prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Family Medicine

Spartanburg, South Carolina, 29303, United States

RECRUITING

Related Publications (1)

  • Stucker M, Pieck C, Stoerb C, Niedner R, Hartung J, Altmeyer P. Topical vitamin B12--a new therapeutic approach in atopic dermatitis-evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial. Br J Dermatol. 2004 May;150(5):977-83. doi: 10.1111/j.1365-2133.2004.05866.x.

    PMID: 15149512BACKGROUND

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Ronald P Januchowski, D.O.

    Spartanburg Regional Healthcare System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald P Januchowski, D.O.

CONTACT

864-560-1558rjanuchowski@srhs.com

Mary E Johnson

CONTACT

864-560-6892mejohnson@srhs.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 25, 2007

Study Start

April 1, 2007

Study Completion

April 1, 2007

Last Updated

April 25, 2007

Record last verified: 2007-04

Locations

US(1)