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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 23, 2007 | ||||||||
| Last Updated Date | April 23, 2007 | ||||||||
| Start Date ICMJE | April 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Reduction in SCORAD at 2 and 4 weeks | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis | ||||||||
| Official Title ICMJE | Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis | ||||||||
| 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 |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Eczema | ||||||||
| Intervention ICMJE | Drug: Topical B12 0.07% | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | April 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 6 Months to 18 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00465699 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | IRB00001369 | ||||||||
| Study Sponsor ICMJE | Spartanburg Regional Family Medicine | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Spartanburg Regional Family Medicine | ||||||||
| Verification Date | April 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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