Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001076662
Ethics application status
Approved
Date submitted
26/09/2014
Date registered
7/10/2014
Date last updated
24/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Moisturisers in the treatment of foot xerosis in adults: Does cost equate to quality? A randomised, double-blinded clinical trial
Scientific title
A randomised controlled trial to compare efficacy between an expensive moisturiser (Eulactol Heel Balm) and inexpensive moisturiser (Sorbolene cream) in the treatment of foot xerosis in adults
Secondary ID [1] 285406 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Xerosis of the foot or feet 293151 0
Condition category
Condition code
Skin 293422 293422 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Moisturiser - Eulactol Heel Balm
Active ingredient: urea. 2g topically applied daily for 4 weeks. Applied by clinician to ensure adherence to treatment.
Intervention code [1] 290326 0
Treatment: Other
Comparator / control treatment
Moisturiser - Walker's Sorbolene
Active ingredient: paraffin. 2g topically applied daily for 4 weeks. Applied by clinician to ensure adherence to treatment.
Control group
Active

Outcomes
Primary outcome [1] 293248 0
SRRC score, evaluation scaling roughness, redness and cracks.
Timepoint [1] 293248 0
Baseline & 4 weeks
Secondary outcome [1] 310664 0
VAS score measuring patient - perceived satisfaction of treatment
Timepoint [1] 310664 0
4 weeks
Secondary outcome [2] 310731 0
Patient satisfaction with intervention as scored by VAS
Timepoint [2] 310731 0
4 weeks

Eligibility
Key inclusion criteria
Male or female aged >18 yrs

Diagnosis of xerosis indicated by a SRRC score of >2 in dorsal / plantar foot as diagnosed by clinician

Willing and able to provide written consent

Bilateral Xerosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Co-existing dermatological disease which may influence xerosis presentation

Co-existing systemic disease which may affect skin physiology

Medications which affect skin integrity / physiology

Allergies to moisturiser ingredients

Concomitant moisturiser, antifungal or steroid use

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Upon being screened for inc / exc criteria, participants wiil be randomised & assigned to groups with a 3rd party handing out opaque envelopes revealing allocation to 'A' or 'B' groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated into intervention groups via simple randomisation conducted using computerised online sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2014
Actual
1/02/2015
Date of last participant enrolment
Anticipated
Actual
1/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 290011 0
University
Name [1] 290011 0
University Of South Australia
Country [1] 290011 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
EDS House North Terrace, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 288753 0
None
Name [1] 288753 0
Address [1] 288753 0
Country [1] 288753 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291718 0
UniSA Human Research Ethics Committee
Ethics committee address [1] 291718 0
EDS House North Terrace, Adelaide SA 5001
Ethics committee country [1] 291718 0
Australia
Date submitted for ethics approval [1] 291718 0
Approval date [1] 291718 0
23/09/2014
Ethics approval number [1] 291718 0

Summary
Brief summary
Trial to test difference in efficacy between an expensive moisturiser (Eulactol Heel Balm) & inexpensive moisturiser (Walker's Sorbolene) in the treatment of foot xerosis over a 4 weeks period. A secondary cost / benefit analysis will also be conducted to help determine 'value for money' of the interventions
Trial website
Trial related presentations / publications
None to date
Public notes

Contacts
Principal investigator
Name 51734 0
Mr Justin Parker
Address 51734 0
UniSA
108 North Terrace, Adelaide SA 5001
Country 51734 0
Australia
Phone 51734 0
61421336075
Fax 51734 0
Email 51734 0
parjc003@mymail.unisa.edu.au
Contact person for public queries
Name 51735 0
Mr Justin Parker
Address 51735 0
UniSA
108 North Terrace, Adelaide SA 5001
Country 51735 0
Australia
Phone 51735 0
61421336075
Fax 51735 0
Email 51735 0
parjc003@mymail.unisa.edu.au
Contact person for scientific queries
Name 51736 0
Mr Justin Parker
Address 51736 0
UniSA
108 North Terrace, Adelaide SA 5001
Country 51736 0
Australia
Phone 51736 0
61421336075
Fax 51736 0
Email 51736 0
parjc003@mymail.unisa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.