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...
Date First Received: April 23, 2007
Last Updated: April 23, 2007
Verified by: Spartanburg Regional Family Medicine, April 2007
Clinical Trial Phase: N/A | Start Date: April 2007
Overall Status: Recruiting
Estimated Enrollment: 50
Brief Summary
Official Title: “Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis”
Condition Keyword(s):
Intervention(s):
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
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Topical B12 0.07%
Outcome Measures for this Clinical Trial
Primary Measures
- Reduction in SCORAD at 2 and 4 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Months
Maximum Age for this Clinical Trial: 18 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Spartanburg Regional Family Medicine
Overall Clinical Trial Officials and Contacts
Ronald P Januchowski, D.O. Principal Investigator Spartanburg Regional Family Medicine
Overall Contact: Ronald P Januchowski, D.O. 864-560-1558 rjanuchowski@srhs.com
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00465699
Study ID Number: IRB00001369
ClinicalTrials.gov Identifier: NCT00465699
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
