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Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis

This study is currently recruiting participants.
Verified by Spartanburg Regional Family Medicine, April 2007

Sponsored by: Spartanburg Regional Family Medicine
Information provided by: Spartanburg Regional Family Medicine
ClinicalTrials.gov Identifier: NCT00465699
  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%

MedlinePlus related topics:   Eczema  

ChemIDplus related topics:   Vitamin B 12   Hydroxocobalamin  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis

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

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.

  Eligibility
Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
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

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:

Study ID Numbers:   IRB00001369
First Received:   April 23, 2007
Last Updated:   April 23, 2007
ClinicalTrials.gov Identifier:   NCT00465699
Health Authority:   United States: Institutional Review Board

Keywords provided by Spartanburg Regional Family Medicine:
Eczema  
Pediatric  
Vitamin B12  

Study placed in the following topic categories:
Hypersensitivity
Dermatitis, Atopic
Hydroxocobalamin
Hypersensitivity, Immediate
Vitamin B 12
Skin Diseases, Eczematous
Eczema
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:
Immune System Diseases
Genetic Diseases, Inborn
Skin Diseases

ClinicalTrials.gov processed this record on July 03, 2008




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