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Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Spartanburg Regional Family Medicine.
Recruitment status was  Recruiting
Sponsor:
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
  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

Resource links provided by NLM:

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
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:

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

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 May 19, 2013