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ID
Source
Brief title
Health condition
Skin hydratation in type 2 diabetic patient evaluated with standard DASI score (Dry Assessement Skin Xerosis)
Sponsors and support
Department of Podology Service
Monte rotondo Rome (Italy)
Company Support regarding only study products (Urea lotion and control cream)
Intervention
Outcome measures
Primary outcome
1. DASI score;
2. Physician Global Assessement (score scale from 0 to 3).
Secondary outcome
Tolerability will be assesed with a patient Assessement score (from 0: very good tolerability tolerability to 3: not tolerated at all) at each visit.
Background summary
Xerosis 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.
Study objective
Topical 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.
Study design
1. Baseline;
2. Week 2;
3. Week 4.
Intervention
Investigational 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.
Inclusion criteria
1. 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 criteria
1. Diabetic foot;
2. Severe neuropathy;
3. Severe vasculopathy;
4. Insulin treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL3184 |
| NTR-old | NTR3328 |
| Other | : ADI-DB-01-12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |