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NCT00465699 Clinical Trial

Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis

Eczema Clinical Trial

Official title:
Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00465699
Other study ID # IRB00001369
Secondary ID
Status Unknown status
Phase N/A
First received April 23, 2007
Last updated April 23, 2007
Start date April 2007
Est. completion date April 2007

Study information
Verified date April 2007
Source Spartanburg Regional Family Medicine
Contact Ronald P Januchowski, D.O.
Phone 864-560-1558
Email rjanuchowski@srhs.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 50
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Topical B12 0.07%

Locations
Country Name City State
United States Center for Family Medicine Spartanburg South Carolina

Sponsors (1)
Lead Sponsor Collaborator
Spartanburg Regional Family Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stücker 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in SCORAD at 2 and 4 weeks
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