Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000782538
Ethics application status
Approved
Date submitted
14/07/2015
Date registered
28/07/2015
Date last updated
19/11/2020
Date data sharing statement initially provided
27/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, double blind, placebo controlled comparative trial of Ceramide Cream and Ceramide Cleanser in the management of moderate eczema in adults
Scientific title
A randomised, double blind, placebo controlled comparative trial of Ceramide Cream and Ceramide Cleanser in the management of moderate eczema in adults
Secondary ID [1] 287085 0
None
Universal Trial Number (UTN)
U1111-1172-1554
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eczema 295595 0
Condition category
Condition code
Skin 295872 295872 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The will investigate the efficacy of two cosmetic products, a ceramide-dominant physiological lipid-based hydrating cleanser and moisturiser. The Cream will be applied liberally to the whole body twice a day, while the Cleanser will be used on the whole body once a day. Duration of use will be for 28 days. Compliance will be monitored by weighing the products at each study visit. Both products are regulated as cosmetics, and as such do not have 'active' ingredients. Both products contain ceramides, cholesterol and physiological lipids in a 3:1:1 ratio.
Intervention code [1] 292325 0
Lifestyle
Intervention code [2] 292372 0
Treatment: Other
Comparator / control treatment
The placebo cleanser will contain a blend of surfactants, while the placebo cream will contain a blend of emulsifiers, fatty alcohols and thickeners. These placebo products are the intervention products with the ceramide components removed.
Control group
Placebo

Outcomes
Primary outcome [1] 295552 0
The primary efficacy endpoint will be the percentage change from baseline in EASI score at Day 28 for both the PP and ITT populations. The outcome to be assessed by the EASI score is eczema severity.
Timepoint [1] 295552 0
Day 28
Secondary outcome [1] 315840 0
The percentage change from baseline in the EASI score. The outcome to be assessed by the EASI score is eczema severity.
Timepoint [1] 315840 0
Day 7, 14 and 21
Secondary outcome [2] 315841 0
The percentage change from baseline in trans epidermal water loss (TEWL). TEWL is determined by the use of a hand held Tewameter.
Timepoint [2] 315841 0
Day 7, 14, 21 and 28
Secondary outcome [3] 315842 0
The percentage change from baseline in skin hydration. Skin hydration is determined by the use of a handheld Corneometer.
Timepoint [3] 315842 0
Day 7, 14, 21 and 28
Secondary outcome [4] 315843 0
The change in DLQI from baseline. The DLQI, Dermatology Quality Index Survey, will be used to assess changes in quality of life.
Timepoint [4] 315843 0
Day 14 and 28
Secondary outcome [5] 315844 0
Patient satisfaction survey. This survey has been designed for this study and will be used to assess subject attitudes towards the test products.
Timepoint [5] 315844 0
Day 14 and 28
Secondary outcome [6] 315845 0
The amount of Zatamil Hydrogel used as rescue medication. The amount of Zatamil Hydrogel used will be determined by weighing the product at each assessment visit.
Timepoint [6] 315845 0
Day 7, 14, 21 and 28
Secondary outcome [7] 315846 0
Type of adverse events, and their relationship to the investigational products. The most common type of adverse events from topical cosmetic cleansers and creams is irritation. This may present as itch and/or rash. These will be assessed via subject self reporting and medical observation/queries at each clinical visit.
Timepoint [7] 315846 0
Day 7, 14, 21 and 28
Secondary outcome [8] 315989 0
Frequency of adverse events, and their relationship to the investigational products. Adverse events from cosmetic cleansers and creams are rare. These will be assessed via subject self reporting and medical observation/queries at each clinical visit.
Timepoint [8] 315989 0
Day 7, 14, 21 and 28
Secondary outcome [9] 315990 0
Severity of adverse events, and their relationship to the investigational products. Adverse events from cosmetic cleansers and creams are usually mild. These will be assessed via subject self reporting and medical observation/queries at each clinical visit.
Timepoint [9] 315990 0
Day 7, 14, 21 and 28

Eligibility
Key inclusion criteria
1. Male or females over 18 years of age.
2. A confirmed diagnosis of eczema according to the criteria of Hanifin & Rajka for at least one year, with moderate severity (score of 10-20) as evaluated with the EASI.
3. Free of any dermatological or systemic disorder which could interfere with the results, at the discretion of the Investigator.
4. Free of any acute or chronic disease that may interfere with or increase the risk of study participation.
5. Completed a preliminary medical history form.
6. Have read, understood and signed an informed consent document relating to the specific type of study they are subscribing.
7. Able to cooperate with the Investigator and research staff, willing to have the test materials applied according to the protocol, and complete the full course of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Individuals under 18 years of age.
2. History of allergies or adverse reactions to moisturisers or the components of the specific products being tested.
3. Use of other moisturising products or other topical eczema therapies in the week prior to participation in this trial.
4. Use of other moisturising products or other topical eczema therapies during the trial.
5. Individuals taking any medication (topical or systemic) that may mask or interfere with the test results, i.e. calcineurin inhibitors, oral corticosteroids.
6. A history of any acute or chronic disease that may interfere with or increase the risk of study participation.
7. Excessive hair on the test sites.
8. Individuals diagnosed with chronic skin allergies.
9. Pregnant or nursing females.

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)
Allocation concealment is achieved using numbered containers. Trial product will be randomised and labelled/numbered by the Sponsor. When a subject is enrolled they will be assigned the next randomisation number and given the matching products.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated by using SAS 'Registered trademark' statistical software. The randomisation will be constructed to ensure balanced assignment to the study products as time progresses.
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
To determine the number of subjects needed a power analysis was used. This power analysis has shown that assuming an alpha (a) of 0.05, power (1-ß) of 0.8, a difference between group means of 12% and a standard deviation of 20, approximately 50 subjects per group are required.

The Student’s t-test will be used to test if there is a statistically significant difference in EASI score, TEWL, skin hydration, DLQI and quantity of Zatamil Hydrogel used in the active and placebo groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2015
Actual
12/09/2015
Date of last participant enrolment
Anticipated
20/12/2019
Actual
3/10/2019
Date of last data collection
Anticipated
Actual
31/10/2019
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9963 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 291647 0
Commercial sector/Industry
Name [1] 291647 0
Ego Pharmaceuticals Pty Ltd
Country [1] 291647 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ego Pharmaceuticals Pty Ltd
Address
21-31 Malcolm Road
Braeside Vic 3195
Country
Australia
Secondary sponsor category [1] 290315 0
None
Name [1] 290315 0
Address [1] 290315 0
Country [1] 290315 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293173 0
Bellberry Limtied
Ethics committee address [1] 293173 0
Ethics committee country [1] 293173 0
Australia
Date submitted for ethics approval [1] 293173 0
Approval date [1] 293173 0
22/06/2015
Ethics approval number [1] 293173 0
2015-04-270

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

Contacts
Principal investigator
Name 58774 0
Dr Stephen Shumack
Address 58774 0
St George Dermatology and Skin Cancer Centre
Belgrave St Unit Trust
Level 3, 22 Belgrave Street
Kogarah
New South Wales 2217
Country 58774 0
Australia
Phone 58774 0
+61295874277
Fax 58774 0
Email 58774 0
[email protected]
Contact person for public queries
Name 58775 0
Fabrizio Spada
Address 58775 0
Ego Pharmaceuticals
21-31 Malcolm Road
Braeside Vic 3195
Country 58775 0
Australia
Phone 58775 0
+61395868874
Fax 58775 0
Email 58775 0
[email protected]
Contact person for scientific queries
Name 58776 0
Fabrizio Spada
Address 58776 0
Ego Pharmaceuticals
21-31 Malcolm Road
Braeside Vic 3195
Country 58776 0
Australia
Phone 58776 0
+61395868874
Fax 58776 0
Email 58776 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
The data will be elaborated by statistician to determine significance of treatment vs placebo.


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.