Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Spartanburg Regional Family Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Spartanburg Regional Family Medicine
ClinicalTrials.gov Identifier:
NCT00465699
First received: April 23, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted

April 23, 2007
April 23, 2007
April 2007
Not Provided
Reduction in SCORAD at 2 and 4 weeks
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis
Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Eczema
Drug: Topical B12 0.07%
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
April 2007
Not Provided

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
Both
6 Months to 18 Years
Yes
Contact: Ronald P Januchowski, D.O. 864-560-1558 rjanuchowski@srhs.com
Contact: Mary E Johnson 864-560-6892 mejohnson@srhs.com
United States
 
NCT00465699
IRB00001369
Yes
Not Provided
Spartanburg Regional Family Medicine
Not Provided
Principal Investigator: Ronald P Januchowski, D.O. Spartanburg Regional Family Medicine
Spartanburg Regional Family Medicine
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP