An urea, arginine and carnosine cream shows greater efficacy in the treatment of severe xerosis of the feet in type 2 diabetic patients in comparison with standard emollient glycerol cream.

ISRCTN ISRCTN13923163
DOI https://doi.org/10.1186/ISRCTN13923163
Secondary identifying numbers UR012014
Submission date
16/03/2015
Registration date
24/04/2015
Last edited
24/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Xerosis, is an abnormal dryness of the skin. It is one of the most common skin conditions in people with type 2 diabetes. Symptoms include dry, rough skin which, as the condition progresses, becomes red, scaly in appearance. Cracks and fissures may also develop and the skin becomes less elastic and less able to withstand trauma. This can all lead to breaking down of the skin and infections. As yet, there is no long term data available on the effects of emollients in treating severe kin xerosis of the foot in diabetics. Here, we want to investigate how well a urea, arginine and carnosine cream (UC) works in comparison with a glycerin-based emollient cream (SEC), in type 2 diabetics with severe xerosis of the feet.

Who can participate?
Adults aged 40-75 with type 2 diabetes and moderate-to-severe feet skin dryness

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are treated with UC twice a day for 32 weeks. Those in group 2 are treated with SEC twice a day for 32 weeks. The severity of the xerosis is assessed using a 9-point Xerosis-Assessment-Scale (XAS) score and a 4-point Overall-Cutaneous-Score (OCS), at the start of the study, and then after 4, 12 and finally 32 weeks.

What are the possible benefits and risks of participating?
Benefits includes regular visits assess the skin condition of the feet and being supplied with emollients for the duration of the trial. No particular risks have been identified in taking part.

Where is the study run from?
Diabetic Foot Service, Monterotondo, Rome (Italy)

When is the study starting and how long is it expected to run for?
November 2013 to June 2014

Who is funding the study?
Isdin SA, Barcelona (Spain)

Who is the main contact?
Dr Massimo Milani

Contact information

Dr Massimo Milani
Scientific

Viale Abruzzi 3
Milan
20123
Italy

ORCiD logoORCID ID 0000-0001-7559-1202

Study information

Study designA mono-centre prospective, 8-month, randomised, parallel groups, assessor-blinded trial, carried out in a secondary-level diabetic clinic in Italy
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific titleAn urea, arginine and carnosine cream shows greater efficacy in the treatment of severe xerosis of the feet in type 2 diabetic patients in comparison with standard emollient glycerol cream: a randomized, 8-month, assessor-blinded, controlled trial.
Study objectivesWe evaluated and compared the efficacy of 8-month treatment with urea 5%, arginine 0.4% and carnosine, 0.01% (UC) cream (Ureadin Podos Db cream, Isdin, Spain) in comparison with a standard high content glycerol-based (40%) emollient topical product (SEC) (Neutrogena Norwegian Formula Dermatological Cream, Johnson and Johnson), in type 2 diabetic patients with skin xerosis of lower limbs.
Ethics approval(s)Diabetic Foot Service Monterotondo Rome (Italy), October 2013
Health condition(s) or problem(s) studiedType 2 diabetes mellitus and severe foot skin xerosis
InterventionUrea 5%, arginine and carnosine cream vs glycerin 40% cream
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III/IV
Drug / device / biological / vaccine name(s)1. Ureadin Podos Db 2. Neutrogena
Primary outcome measureEvolution of a 9-point grading Xerosis Assessment Scale (XAS) score (from 0 to 8) and of a 4-point grading Overall Cutaneous Score (OCS) (from 0 to 3) both evaluated at baseline, after 4, 12, and 32 weeks by an investigator unaware of treatment allocation.
Secondary outcome measures1. The evolution of skin hydration and desquamation evaluated semi-quantitatively by means of Hydr8®, a bio-impedance analysis device, carried out at baseline and at week 32
2. The percentage of patients with very severe skin xerosis (i.e. XAS score>5) at baseline showing an improvement ≥3 points at the end of 32 weeks of treatment.
Overall study start date01/11/2013
Completion date30/06/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants50
Key inclusion criteria1. Adult men and women, aged between 40 and 75 years,
2. Confirmed diagnosis of type 2 diabetes
3. Moderate-to-severe feet skin dryness,
4. Not used any topical moisturizers on their feet for at least 2 weeks preceding enrolment visit
Key exclusion criteria1. Insulin dependent diabetes mellitus
2. Presence or past history of foot ulcers lesions
3. Clinical evident peripheral arterial diseases (i.e. ankle/arm systolic blood pressure ratio <0.8)
4. Acute or chronic Charcot osteoarthropathy
5. Clinical significant neuropathy
6. Acute skin diseases and use of drugs that might affect sweating were the main exclusion criteria
Date of first enrolment01/11/2013
Date of final enrolment01/02/2014

Locations

Countries of recruitment

  • Italy

Study participating centre

Diabetic Foot Service
Monterotondo
Rome
Italy

Sponsor information

Isdin SA
Industry

Calle Provencals 33
Barcelona
20131
Spain

ROR logo "ROR" https://ror.org/04dg86p75

Funders

Funder type

Industry

Isdin SA, Barcelona (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination plan
IPD sharing plan