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Efficacy of topical urea in comparison with standard cream in foot skin xerosis in type 2 diabetic patients: A randomised investigator blinded study.


- candidate number11265
- NTR NumberNTR3328
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mrt-2012
- Secondary IDsADI-DB-01-12 
- Public TitleEfficacy of topical urea in comparison with standard cream in foot skin xerosis in type 2 diabetic patients: A randomised investigator blinded study.
- Scientific TitleComparison of efficacy of topical 10% urea with standard emollient cream in DASI score in lower arm of type 2 patients.
- ACRONYMUreadin DB 01
- hypothesisTopical urea is a gold standard treatment for xerosis. Skin xerosis is commonly observed in diabetic subject. A correct hydratation of the skin is advised in order to reduce the risk of skin lesions such as ulcer. No comparative data are available comparing the hydrating and emollient efficacy of topical 10% urea in comparison with standard cream.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), DASI score (Dry Assessement Skin Xerosis)
- Inclusion criteria1. Type 2 diabetes in diet or oral treatment;
2. Hystory of diabetes since at least 6 years;
3. Age 40-80 years;
4. Men or women.
- Exclusion criteria1. Diabetic foot;
2. Severe neuropathy;
3. Severe vasculopathy;
4. Insulin treatment.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2012
- planned closingdate1-apr-2012
- Target number of participants40
- InterventionsInvestigational product:
Topical urea in lotion (fluid cream) formulation 10% containing also arginine and carnosine.

Control:
Emollient cream containing glycerol.

Both products will be applied 2 times a day on the feet and in the 2/3 distal lower leg.
- Primary outcome1. DASI score;
2. Physician Global Assessement (score scale from 0 to 3).
- Secondary outcomeTolerability will be assesed with a patient Assessement score (from 0: very good tolerability tolerability to 3: not tolerated at all) at each visit.
- Timepoints1. Baseline;
2. Week 2;
3. Week 4.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. Massimo Milani
- CONTACT for SCIENTIFIC QUERIESMD. Massimo Milani
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryXerosis is a common skin alteration found in diabetic patients.
Topical urea is considered a efficaious emollient treatment.
No comparative head-to-head trials have been performed to evaluate hydrating and emollient efficacy between topical products.
- Main changes (audit trail)
- RECORD1-mrt-2012 - 16-mrt-2012


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