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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12614001076662 |
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Date of registration:
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07/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Moisturisers in the treatment of foot xerosis in adults: Does cost equate to quality? A randomised, double-blinded clinical trial
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Scientific title:
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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 |
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Date of first enrolment:
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01/02/2015 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12614001076662.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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Mr Justin Parker
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Address:
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UniSA
108 North Terrace, Adelaide SA 5001
Australia |
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Telephone:
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61421336075 |
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Email:
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parjc003@mymail.unisa.edu.au |
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Affiliation:
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Name:
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Mr Justin Parker
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Address:
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UniSA
108 North Terrace, Adelaide SA 5001
Australia |
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Telephone:
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61421336075 |
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Email:
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parjc003@mymail.unisa.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Skin - Dermatological conditions
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Xerosis of the foot or feet;
Xerosis of the foot or feet
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Intervention(s)
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Moisturiser - Eulactol Heel Balm
Active ingredient: urea. 2g topically applied daily for 4 weeks. Applied by clinician to ensure adherence to treatment.
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Primary Outcome(s)
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SRRC score, evaluation scaling roughness, redness and cracks.[Baseline & 4 weeks]
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Secondary Outcome(s)
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Patient satisfaction with intervention as scored by VAS[4 weeks]
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VAS score measuring patient - perceived satisfaction of treatment [4 weeks]
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Source(s) of Monetary Support
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University Of South Australia
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Ethics review
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Status: Approved
Approval date:
Contact:
UniSA Human Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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