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Trial registered on ANZCTR


Registration number
ACTRN12615001343594
Ethics application status
Approved
Date submitted
24/11/2015
Date registered
9/12/2015
Date last updated
8/01/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
N/A

Titles & IDs
Public title
Epaderm ointment in children with eczema
Scientific title
Pilot study comparing two emollients, Emulsifying ointment B.P. and Epaderm topical ointment in children with eczema
Secondary ID [1] 287960 0
nil
Universal Trial Number (UTN)
U1111-1167-0979
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eczema 296838 0
Condition category
Condition code
Skin 297069 297069 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised single subject double-blind parallel superiority trial of two emollients: Epaderm ointment (active ingredient Cetomacrogol Emulsifying Wax BP) and Emulsifying ointment (BP)(active ingredient white soft paraffin and liquid paraffin) . Each emollient will be randomly assigned for application to one or other side (sagittal plane) of the body as required, but at least once a day, on the affected area for 8 weeks.. Each emollient will always be applied to the same side and will be clearly marked “for use of XXX (child in study) only” and “for use on left side only” or “for use on right side only”.
Parents will be asked to record if they have mistakenly applied the emollient to the wrong side in the study diary and will be asked to bring both containers of study emollient to every clinic visit (week 2, 4, 6 and 8) so they can be weighed by the study staff.
Intervention code [1] 293304 0
Treatment: Other
Comparator / control treatment
Epaderm ointment
Control group
Active

Outcomes
Primary outcome [1] 296676 0
Change in SCORAD scores for skin treated with Emulsifying ointment(BP) and with Epaderm at baseline and at 2 weekly intervals for a total of 8 weeks.
Timepoint [1] 296676 0
After 60 participants have been recruited and treated for 8 weeks, with study assessments completed at the baseline, week 2, 4, 6, and 8 will be final study visit/assessment.
Secondary outcome [1] 319087 0
Differences between SCORAD and EASI as tools for assessing eczema severity will be measured on each side of the body at baseline and at 2 weekly intervals for a total of 8 weeks.
Timepoint [1] 319087 0
After 60 participants have been recruited and treated for 8 weeks, with study assessments completed at the baseline, week 2, 4, 6, and 8 will be final study visit/assessment.
Secondary outcome [2] 319088 0
To assess the usefulness of measuring skin temperature in children with skin inflammation due to eczema by using infrared camera. We will compare mean side skin temperature measurements with SCORAD scores on skin treated with the two emollients
Timepoint [2] 319088 0
After 60 participants have been recruited and treated for 8 weeks, with study assessments completed at the baseline, week 2, 4, 6, and 8 will be final study visit/assessment.
Secondary outcome [3] 319089 0
To compare skin flora on affected and unaffected skin prior to and after treatment with the two emollients by swabbing at the baseline and week 8.
Timepoint [3] 319089 0
After 60 participants have been recruited and treated for 8 weeks, with study assessments completed at the baseline, week 2, 4, 6, and 8 will be final study visit/assessment.

Eligibility
Key inclusion criteria
a) Eczema with a severity on SCORAD of greater or equal to 5 for objective measures only
b) Children with eczema aged 0-5
c) Parent/caregiver must be able to speak enough English to understand the trial and be able to complete the trial diary
Minimum age
No limit
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Other serious chronic disease that may require immunosuppressive therapy, as decided on a case by case basis by the principal investigator.
b) Use of systemic antibacterial therapy within one week prior to starting study treatment
c) Patients with co-morbid conditions that would require long term systemic corticosteroid therapy during study treatment. Systemic steroid use for less or equal to 5 days for another reason such as asthma is permissible.
d) Severe eczema requiring regular use of potent topical steroids
e) Family unable to comply with study requirements as judged by the investigator, such as the desire to use other non-study eczema medications unless medically indicated
f) Use of potent topical steroids within one month of enrolment (e.g. mometasone, betamethasone, fluticasone, clobetasol)

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)
The list specifying which treatment is to be applied to which side of the body (for any given participant) will be held in a central administrative file. The nature of the study materials (emollient) is blinded for investigators and participants, and so this randomisation file will use coded allocations (e.g. "A" for the control emollient, "B" for the intervention emollient.)
When a new participant enters the trial, the Study Nurse will contact the administrator of this file (who will be an appropriate staff member not otherwise involved in the study) who will tell the study nurse the next randomisation from this list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation:

The random list of which treatment (A/B) is to be applied to which side of the patient's body (left/right) will be generated using a random number generator (in the statistical package R). Each trial allocation will be either "A -- left, B -- right" or "A -- right, B -- left". A total of 60 randomised allocations will be created in this file. The randomisation will be blocked, in order to minimise the impact of randomisation imbalance if the trial ends early due to low recruitment
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As data are paired (each child receives both treatments simultaneously) analysis will need to take this into account. All analyses will be intention-to-treat.
The analysis of the primary outcome, treated as a continuous outcome, will use mixed linear model methods to analyse the outcomes. Measurements at the two-month follow up will be compared between the intervention/control paired study conditions, adjusted for baseline scores. The mixed models approach allows for calculation of within-subjects correlation to properly account for the paired nature of the measurements.
The mixed linear model design can partially compensate for participant dropout (presuming that there is at least some follow-up data for each participant.)
Sample size estimates are predicted around detecting a difference between emollients of around 10% from baseline measurements. Based on current estimates, this would be a difference of 3 to 3.5 points. The analysis (mixed linear model adjusting for baseline as covariate) is closely aligned to analysis of covariance (ANCOVA) Therefore with a baseline standard deviation of 10.5 points, and a pre-post correlation of 0.68 a sample size of 46 would have 87% power to detect a difference of 3.5 points). The sample size of sixty patients allows for an approx. 25% drop out rate.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
30/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 7352 0
New Zealand
State/province [1] 7352 0
Wellington

Funding & Sponsors
Funding source category [1] 292434 0
Government body
Name [1] 292434 0
Capital and Coast District Health Board
Country [1] 292434 0
New Zealand
Primary sponsor type
Government body
Name
Capital and Coast District Health board
Address
Research Office, Level 8, CSB, Wellington hospital, Riddiford Street, Wellington , New Zealand 6021
Country
New Zealand
Secondary sponsor category [1] 291128 0
None
Name [1] 291128 0
none
Address [1] 291128 0
none
Country [1] 291128 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293894 0
The Southern Health and Disability Ethics Committee
Ethics committee address [1] 293894 0
Ministry of Health
Freyberg Building
20 Aitken Street
Wellington 6011
Ethics committee country [1] 293894 0
New Zealand
Date submitted for ethics approval [1] 293894 0
02/09/2015
Approval date [1] 293894 0
23/09/2015
Ethics approval number [1] 293894 0
15/STH/152

Summary
Brief summary
Atopic eczema is a chronic relapsing skin condition that affects 5 to 20% of children under the age of 10. Eczema can affect the quality of life of the children and their parents/caregivers as well as being a financial burden to families and the health care system. We aim to compare the efficacy of Epaderm ointment with that of a standard ointment in decreasing the severity of eczema in 50 children under the age of 5.
We will measure eczema severity using validated SCORAD and EASI scoring systems and by taking infrared photographs of the skin (to measure erythema).
We will also take swab samples of the affected and unaffected skin at the start and the end of the trial to determine if the microbiota of the skin is affected by 1] eczema and 2] the different ointments.
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 61718 0
Prof Dr Thorsten Stanley
Address 61718 0
University of Otago, Wellington
23A Mein Street, Newtown,Wellington 6242
Country 61718 0
New Zealand
Phone 61718 0
+6443855999
Fax 61718 0
+6443855496
Email 61718 0
[email protected]
Contact person for public queries
Name 61719 0
Marina Dzhelali
Address 61719 0
Research Office, Level 8, CSB, Wellington Hospital, Riddiford Street, Wellington 6021
Country 61719 0
New Zealand
Phone 61719 0
+6449185117
Fax 61719 0
+6443855496
Email 61719 0
[email protected]
Contact person for scientific queries
Name 61720 0
Dr Thorsten Stanley
Address 61720 0
University of Otago, Wellington
23A Mein Street, Newtown,Wellington 6242
Country 61720 0
New Zealand
Phone 61720 0
+6443855999
Fax 61720 0
+6443855496
Email 61720 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
trial has not been completed


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.