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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00465699
First Posted: April 25, 2007
Last Update Posted: April 25, 2007
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.
Information provided by:
Spartanburg Regional Family Medicine
  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:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00465699     History of Changes
Other Study ID Numbers: IRB00001369
First Submitted: April 23, 2007
First Posted: April 25, 2007
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


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