EczemaNCT00465699
Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis
A study testing Topical B12 0.07% in people with Eczema, run by Spartanburg Regional Healthcare System at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Eczema
- What is being tested?
- Topical B12 0.07%
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- children presenting to the Center for Family Medicine or Regional Pediatrics between the ages of 6 months and 18 years old with atopic dermatitis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Family Medicine
Spartanburg, South Carolina, 29303
Ronald P Januchowski, D.O.
About this study
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
Read the 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.
- Conditions
- Eczema
- Being tested
- Topical B12 0.07%
- Keywords
- Eczema, Pediatric, Vitamin B12
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical B12 0.07%Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in SCORAD at 2 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startApr 2007
- Study completionApr 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Spartanburg Regional Healthcare System
- Sponsor type
- University, hospital or other
- Investigators
- Ronald P Januchowski, D.O., Principal investigator, Spartanburg Regional Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465699
- Sponsor's protocol ID
- IRB00001369
- Status last verified
- Apr 2007
- First submitted
- 23 Apr 2007
- Last updated
- 25 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15149512
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00465699
- Acronym / sponsor ID
- IRB00001369
- Conditions
- Eczema
- Keywords
- Eczema, Pediatric, Vitamin B12
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Spartanburg Regional Healthcare SystemUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- Apr 2007 (estimated)
- First posted
- 25 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children presenting to the Center for Family Medicine or Regional Pediatrics between the ages of 6 months and 18 years old with atopic dermatitis
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical B12 0.07% | Drug | – |
Primary outcome
Reduction in SCORAD at 2 and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2007.
- Background: PubMed 15149512Stucker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald P Januchowski, D.O. principal investigator
Spartanburg Regional Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical B12 0.07% in people with Eczema, run by Spartanburg Regional Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronald P Januchowski, D.O. (864-560-1558, rjanuchowski@srhs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in SCORAD at 2 and 4 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00465699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2007.