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Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis

NCT ID: NCT00465699

Last Updated: 2007-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-04-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Topical B12 0.07%

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Spartanburg Regional Healthcare System

OTHER

Sponsor Role lead

Principal Investigators

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Ronald P Januchowski, D.O.

Role: PRINCIPAL_INVESTIGATOR

Spartanburg Regional Healthcare System

Locations

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Center for Family Medicine

Spartanburg, South Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ronald P Januchowski, D.O.

Role: CONTACT

[email protected]
864-560-1558

Mary E Johnson

Role: CONTACT

[email protected]
864-560-6892

References

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Stucker M, Pieck C, Stoerb C, Niedner R, Hartung J, Altmeyer P. Topical vitamin B12--a new therapeutic approach in atopic dermatitis-evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial. Br J Dermatol. 2004 May;150(5):977-83. doi: 10.1111/j.1365-2133.2004.05866.x.

Reference Type BACKGROUND
PMID: 15149512 (View on PubMed)

Other Identifiers

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IRB00001369

Identifier Type: -

Identifier Source: org_study_id