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Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by:
Spartanburg Regional Family Medicine

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

Condition or disease Intervention/treatment
Eczema Drug: Topical B12 0.07%

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.


Study Type : Interventional  (Clinical Trial)
Estimated 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources




Primary Outcome Measures :
  1. Reduction in SCORAD at 2 and 4 weeks


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


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

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