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Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis

Primary Purpose

Eczema

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Topical B12 0.07%
Sponsored by
Spartanburg Regional Family Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eczema focused on measuring Eczema, Pediatric, Vitamin B12

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Center for Family MedicineRecruiting

Outcomes

Primary Outcome Measures

Reduction in SCORAD at 2 and 4 weeks

Secondary Outcome Measures

Full Information

First Posted
April 23, 2007
Last Updated
April 23, 2007
Sponsor
Spartanburg Regional Family Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00465699
Brief Title
Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis
Official Title
Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Spartanburg Regional Family Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
INTRODUCTION: Atopic dermatitis is a prevalent disease process in children, affecting up to 20% of children in the United States. Various treatment options are available to treat atopic dermatitis to include topical emollients, topical steroids, and topical calcineurin inhibitors. Each treatment option has benefits and potential risks. This study was done to determine if topical B12 could be a tolerable and efficacious alternative treatment option in this population. METHODS: The study was conducted as a placebo-controlled, double-blind, prospective, randomized clinical trial with intraindividual left ⁄ right comparison. Parents were given 2 containers of creams and instructed to apply the Vitamin B12 cream to one side of the body and the placebo cream to the contralateral side according to the randomization scheme.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema
Keywords
Eczema, Pediatric, Vitamin B12

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Topical B12 0.07%
Primary Outcome Measure Information:
Title
Reduction in SCORAD at 2 and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: children presenting to the Center for Family Medicine or Regional Pediatrics between the ages of 6 months and 18 years old with atopic dermatitis Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald P Januchowski, D.O.
Phone
864-560-1558
Email
rjanuchowski@srhs.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mary E Johnson
Phone
864-560-6892
Email
mejohnson@srhs.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald P Januchowski, D.O.
Organizational Affiliation
Spartanburg Regional Family Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Family Medicine
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald P Januchowski, D.O.

12. IPD Sharing Statement

Citations:
PubMed Identifier
15149512
Citation
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.
Results Reference
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Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis

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