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| Descriptive Information Fields | |||||||||
| 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 | ||||||||
| 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 † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Reduction in SCORAD at 2 and 4 weeks | ||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Eczema | ||||||||
| Intervention † | Drug: Topical B12 0.07% | ||||||||
| MEDLINE PMIDs | 15149512 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 50 | ||||||||
| Start Date † | April 2007 | ||||||||
| Completion Date | April 2007 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 6 Months to 18 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00465699 | ||||||||
| Organization ID | IRB00001369 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Spartanburg Regional Family Medicine | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Spartanburg Regional Family Medicine | ||||||||
| Verification Date | April 2007 | ||||||||
| First Received Date † | April 23, 2007 | ||||||||
| Last Updated Date | April 23, 2007 | ||||||||
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