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

Comparison of efficacy of topical 10% urea with standard emollient cream in DASI score in lower arm of type 2 patients.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20899

Enrollment

Registered

2012-03-01

Start date

2012-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin hydratation in type 2 diabetic patient evaluated with standard DASI score (Dry Assessement Skin Xerosis)

Interventions

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

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Diabetic foot; 2. Severe neuropathy; 3. Severe vasculopathy; 4. Insulin treatment.

Design outcomes

Primary

Measure	Time frame
1. DASI score; 2. Physician Global Assessement (score scale from 0 to 3).	—

Secondary

Measure	Time frame
Tolerability will be assesed with a patient Assessement score (from 0: very good tolerability tolerability to 3: not tolerated at all) at each visit.	—

Contacts

Public ContactMassimo Milani

Via Nota 18

masmilan2000@yahoo.it0039026431247

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)