Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis
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ClinicalTrials.gov Identifier: NCT00465699 |
Recruitment Status
: Unknown
Verified April 2007 by Spartanburg Regional Family Medicine.
Recruitment status was: Recruiting
First Posted
: April 25, 2007
Last Update Posted
: April 25, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Eczema | Drug: Topical B12 0.07% | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis |
Study Start Date : | April 2007 |
Estimated Study Completion Date : | April 2007 |

- Reduction in SCORAD at 2 and 4 weeks

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Ages Eligible for Study: | 6 Months to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465699
Contact: Ronald P Januchowski, D.O. | 864-560-1558 | rjanuchowski@srhs.com | |
Contact: Mary E Johnson | 864-560-6892 | mejohnson@srhs.com |
United States, South Carolina | |
Center for Family Medicine | Recruiting |
Spartanburg, South Carolina, United States, 29303 | |
Principal Investigator: Ronald P Januchowski, D.O. |
Principal Investigator: | Ronald P Januchowski, D.O. | Spartanburg Regional Family Medicine |
Publications:
ClinicalTrials.gov Identifier: | NCT00465699 History of Changes |
Other Study ID Numbers: |
IRB00001369 |
First Posted: | April 25, 2007 Key Record Dates |
Last Update Posted: | April 25, 2007 |
Last Verified: | April 2007 |
Keywords provided by Spartanburg Regional Family Medicine:
Eczema Pediatric Vitamin B12 |
Additional relevant MeSH terms:
Dermatitis Dermatitis, Atopic Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |