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Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Spartanburg Regional Family Medicine.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Spartanburg Regional Family Medicine
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
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Purpose
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
| Condition | Intervention |
|---|---|
| Eczema | Drug: Topical B12 0.07% |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
atopic dermatitis
MedlinePlus related topics:
Eczema
U.S. FDA Resources
Further study details as provided by Spartanburg Regional Family Medicine:
Primary Outcome Measures:
- Reduction in SCORAD at 2 and 4 weeks
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | April 2007 |
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.
Eligibility| Ages Eligible for Study: | 6 Months to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465699
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465699
Contacts
| Contact: Ronald P Januchowski, D.O. | 864-560-1558 | rjanuchowski@srhs.com | |
| Contact: Mary E Johnson | 864-560-6892 | mejohnson@srhs.com |
Locations
| United States, South Carolina | |
| Center for Family Medicine | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| Principal Investigator: Ronald P Januchowski, D.O. | |
Sponsors and Collaborators
Spartanburg Regional Family Medicine
Investigators
| Principal Investigator: | Ronald P Januchowski, D.O. | Spartanburg Regional Family Medicine |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00465699 History of Changes |
| Other Study ID Numbers: |
IRB00001369 |
| Study First Received: | April 23, 2007 |
| Last Updated: | April 23, 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 |
ClinicalTrials.gov processed this record on September 21, 2017