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Does local application of betamethasonvalerate 0,1% cream twice a day reduce the complaints of chronic chillblains?


- candidate number6895
- NTR NumberNTR2171
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jan-2010
- Secondary IDsR0000302/Perniones2 UMC St Radboud/Radboud University
- Public TitleDoes local application of betamethasonvalerate 0,1% cream twice a day reduce the complaints of chronic chillblains?
- Scientific TitleBetamethason and complaints of chronic chilblains.
- ACRONYMBCCC
- hypothesisChronic chilblains is a common disease causing major restrictions in daily life, nevertheless little is known about treatment. In a literature search, we found thin evidence of three interventions: fluocinolone cream, nifedipine and vitamin D3. Objective of this study is to study the possible effectivity of betamethasonvaleraat 0,1% cream on the complaints of chronic chilblains.
- Healt Condition(s) or Problem(s) studiedChronic perniosis, Chilblains
- Inclusion criteriaPopulation:
Patients with complaints of chronic chillblains referred to us in the winters of 2009-2010, 2010-2011 and 2011-2012 by GPs in the north west of the Netherlands. And subjects who attended our 2003-2004 study on the effect of vitamin D3.

Inclusion criteria:
1. Age: As of 18 years old;
2. Able to follow instructions and complete a diary;
3. At least 3 weeks of complaints at inclusion: Itching or painful lesions at fingers, toes or other places at the feet or te thighs (the Kibes). The complaints started in the period december to february. There may be swelling and there may be ulceration but these criteria are not obligate.
- Exclusion criteria1. A patient history of inflammatory disease;
2. Pregnancy;
3. Breast feeding;
4. Actual use of a calcium entry blocker;
5. Use of corticosteroid containing cream or ointment in the past four weeks;
6. Ulcera on the places to be treated.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate31-mrt-2012
- Target number of participants60
- InterventionsLocal application on the affected skin parts of betamethasonvalerate 0,1% cream twice a day for a period of six weeks.
- Primary outcomeWe consider the intervention to be effective when a reduction of complaints or disability occurs of 10mm, as recorded by the subjects on a 100mm Visual analogue scale.
- Secondary outcomeSecundary we register side effects: skin irritation an signs of skin atrophy.
- TimepointsMeasuring instrument is a diary used by the subject to record the experienced itch, pain and disability on a 100mm Visual analoge scale (one for each item) on a daily basis. Exposure to cold is registered daily using records of the Royal Netherlands Meteorological Institute (KNMI). There will be 6 face to face contacts: Intake (t1), end of week 1 (t2), end of week 4 (t3), end of week 7 (t4), end of week 10 (t5) and end of week 13 (t6).
Primary and secondary outcomes are evaluated using data before and after intervention or placebo treatment (using data from t2, t4 and t6).
Statistical analyses wil be performed using the repeated measures mixed effects model and with regard to possible temperature change during the rechearch period.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES I.H. Souwer
- CONTACT for SCIENTIFIC QUERIES I.H. Souwer
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBackground:
Chronic chilblains is a common disease causing major restrictions in daily life, nevertheless little is known about treatment. In a literature search, we found thin evidence of three interventions: fluocinolone cream, nifedipine and vitamin D3. This study investigates the possible effectiveness of corticosteroid cream.

Objective:
Does local aplication of betamethasonvalerate 0,1% cream twice a day reduce the complaints of chronic chilblains?

Methods:
The design of the study is a double blind crossover type Randomized Clinical Trial. The study population consist of patients with a confirmed diagnosis. Outcome measurement is the change in severity of the complaints and disability as recorded by the subjects on a 100mm Visual Analogue Scale.
Statistical analyses wil be performed using the repeated measures mixed effects model and with regard to possible temperature change during the rechearch period.
- Main changes (audit trail)
- RECORD19-jan-2010 - 17-mrt-2015


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