Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000868684
Ethics application status
Approved
Date submitted
1/08/2014
Date registered
13/08/2014
Date last updated
20/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study: Comparison of urea-based moisturizers in treating dry skin (xerosis) of the feet.
Scientific title
A study to evaluate the efficacy of different moisturizers with different concentrations of urea for the treatment of dry skin in individuals within a podiatry clinical setting for up to 2 months.
Secondary ID [1] 285096 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry skin of the feet in the general population.
“Dermatological condition/ Skin condition” 292646 0
Condition category
Condition code
Skin 292957 292957 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be allocated one type of urea based moisturiser sufficient for the duration of study, with the brand name of the moisturiser concealed for single-blinding purposes. Participants will be instructed to apply moisturisers to both feet once daily after washing their feet with lukewarm water, such as after a bath/shower.
Participants will also be required to complete an “application diary” for each moisturiser application, recording what day they applied the moisturiser and any concerns they have with it.
The Xerosis status of participants will be assessed during the first consultation and subsequently at 4 weeks intervals for total duration of 8 weeks.

There will be 3 treatment groups. Each group will receive one of the following moisturizers: Dot Heel Repair Balm (10%) (Registered Trademark), Walkers 15% Urea foot cream (Registered Trademark) or Walkers 25% Urea foot cream (Registered Trademark). Each moisturizer has a different concentration of urea, prompting us to evaluate and compare the clinical effectiveness between each.
Intervention code [1] 289943 0
Treatment: Other
Comparator / control treatment
There will be 3 treatment groups. Each group will receive one of the following moisturizers: Dot Heel Repair Balm (10%) (Registered Trademark), Walkers 15% Urea foot cream (Registered Trademark) or Walkers 25% Urea foot cream (Registered Trademark). Each moisturizer has a different concentration of urea, prompting us to evaluate and compare the clinical effectiveness between each.
Control group
Dose comparison

Outcomes
Primary outcome [1] 292815 0
Primary outcome: To evaluate the effectiveness of different commercially available urea-based moisturizer in the treatment of xerosis in the general population for up to 2 months. This will be assessed using Specific Symptom Sum Score (SRRC) and Xerosis Assessment Scale.
Timepoint [1] 292815 0
Timepoint: At baseline, 4, and 8 weeks after intervention commencement.
Secondary outcome [1] 309729 0
Secondary outcome 1: Associated side effects with each of the moisturizer used such as skin allergies, skin deterioration and risks of falls. This will be assessed during each consultation by asking the participant whether they have experienced any side effects as well as assessiing the diary comment section.
Timepoint [1] 309729 0
Secondary outcome 1: Timepoint: At baseline, 4, and 8 weeks after intervention commencement
Secondary outcome [2] 309730 0
Secondary outcome 2: Cost of each of the moisturizers used. This is assessed by calculating the total amount (number of bottles used by each participant times the price per moisturizer) over the duration of the study.
Timepoint [2] 309730 0
Timepoint: At baseline, 4, and 8 weeks after intervention commencement.
Secondary outcome [3] 309731 0
Secondary outcome 3: Ease of use of each of the moisturizer used. This will be assessed by using the Treatment Satisfaction Questionnaire (TSQM-II).
Timepoint [3] 309731 0
Timepoint: At baseline, 4, and 8 weeks after intervention commencement.
Secondary outcome [4] 309732 0
Secondary outcome 4: Overall patient satisfaction related to each of the moisturizer used. This will be assessed by using the Treatment Satisfaction Questionnaire (TSQM-II).
Timepoint [4] 309732 0
Timepoint: At baseline, 4, and 8 weeks after intervention commencement

Eligibility
Key inclusion criteria
Inclusion criteria includes confirmed xerosis of the feet, as estimated by the participant during recruitment, aged 18 years old or older and able to reach feet and apply moisturizer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes topical corticosteroid usage within past 3 months, concurrent dermatological conditions such as eczema, pomphoylx or fungal skin infection that is clinically diagnosed by any health professional, active ulceration on the foot receiving the moisturizing intervention, history of contact allergy, non-palpable pedal pulses, usage of other moisturizers within 2 weeks and Aboriginal or Torres Strait Islander.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/08/2014
Actual
29/08/2014
Date of last participant enrolment
Anticipated
11/09/2015
Actual
11/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289703 0
University
Name [1] 289703 0
University of Western Australia
Country [1] 289703 0
Australia
Primary sponsor type
University
Name
University of WA
Address
M422 35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 288395 0
None
Name [1] 288395 0
Address [1] 288395 0
Country [1] 288395 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291442 0
Human Research Ethics Office
Ethics committee address [1] 291442 0
Ethics committee country [1] 291442 0
Australia
Date submitted for ethics approval [1] 291442 0
Approval date [1] 291442 0
01/07/2014
Ethics approval number [1] 291442 0
RA/4/1/6747

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50386 0
A/Prof A/Prof Laurence Foley
Address 50386 0
University of Western Australia. M422 35 Stirling Hwy, Crawley WA 6009
Country 50386 0
Australia
Phone 50386 0
+614 64884524
Fax 50386 0
Email 50386 0
[email protected]
Contact person for public queries
Name 50387 0
A/Prof Laurence Foley
Address 50387 0
University of Western Australia. M422 35 Stirling Hwy, Crawley WA 6009
Country 50387 0
Australia
Phone 50387 0
+614 64884524
Fax 50387 0
Email 50387 0
[email protected]
Contact person for scientific queries
Name 50388 0
A/Prof Laurence Foley
Address 50388 0
University of Western Australia. M422 35 Stirling Hwy, Crawley WA 6009
Country 50388 0
Australia
Phone 50388 0
+614 64884524
Fax 50388 0
Email 50388 0
[email protected]

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.