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…
ID
Bron
Verkorte titel
Aandoening
Skin hydratation in type 2 diabetic patient evaluated with standard DASI score (Dry Assessement Skin Xerosis)
Ondersteuning
Department of Podology Service
Monte rotondo Rome (Italy)
Company Support regarding only study products (Urea lotion and control cream)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. DASI score;<br>
2. Physician Global Assessement (score scale from 0 to 3).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
1. Baseline;
2. Week 2;
3. Week 4.
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Diabetic foot;
2. Severe neuropathy;
3. Severe vasculopathy;
4. Insulin treatment.
Opzet
Deelname
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