Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis |
- 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 |
| Genders Eligible for Study: | Both |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
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 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Spartanburg Regional Family Medicine:
|
Eczema Pediatric Vitamin B12 |
ClinicalTrials.gov processed this record on March 03, 2015