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Trial registered on ANZCTR


Registration number
ACTRN12615000920594
Ethics application status
Approved
Date submitted
18/08/2015
Date registered
2/09/2015
Date last updated
29/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised double blinded placebo controlled study investigating Atopis for the improvement of skin health in subjects with eczema
Scientific title
A randomised double blinded placebo controlled study investigating Atopis for the improvement of skin health in subjects with eczema
Secondary ID [1] 287300 0
Nil
Universal Trial Number (UTN)
U1111-1171-3932
Trial acronym
DECI2700
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eczema 295935 0
atopic dermatitis 295936 0
Condition category
Condition code
Skin 296198 296198 0 0
Dermatological conditions
Alternative and Complementary Medicine 296266 296266 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Atopis skin cream which contains the extract DEC033 at 10% (contains peptilipids and fatty acids), cetearyl olivate, sorbitan olivate, shea butter, safflower oil, macadamia oil, glycerine, Vitamin E, geogard (preservative), Tangerine Oil, deionised water.
The cream is applied topically twice daily to the affected areas for four weeks. The cream is applied liberally. In the previous clinical trial tubes were returned at each visit and weighed. The subjects used on average 1.3g/day. A daily diary is also used to track usage.
Intervention code [1] 292620 0
Treatment: Other
Comparator / control treatment
Mineral oil, glycerine, emulsifying wax, colour (to match active cream) and deionised water.
Control group
Placebo

Outcomes
Primary outcome [1] 295873 0

Change in redness - as assessed using SCORAD (Visual Analog Scale) and Dermatological Examination by the site investigator
Timepoint [1] 295873 0
Subjects are assessed at baseline, week 2 and week 4 for changes between timepoints.
Primary outcome [2] 295922 0
Change in severity scoring of atopic dermatitis (SCORAD)
Timepoint [2] 295922 0
The subjects are assessed at time 0 baseline, week 2 and week 4 for changes in SCORAD
Primary outcome [3] 295923 0
Change in itching - as assessed using SCORAD (Visual Analog Scale) and Dermatological Examination by the site investigator
Timepoint [3] 295923 0
The subjects are assessed at time 0 baseline, week 2 and week 4 for changes in SCORAD
Secondary outcome [1] 316769 0
Change in the the number of eczema skin lesions - these are measured (length, width, location) by the site investigator and documented using the Dermatological examination documentation form.
Timepoint [1] 316769 0
The subjects are assessed by the site investigator at time 0 baseline, week 2 and week 4 for changes in length, width and number of lesions
Secondary outcome [2] 316933 0
Change in scaling - The subjects are assessed by the site investigator at time 0 baseline, week 2 and week 4 and assessed using visual analogue scale
Timepoint [2] 316933 0
The subjects are assessed for changes at time 0 baseline, week 2 and week 4

Eligibility
Key inclusion criteria
1. Healthy male or female between 16 and 70 years of age.
2. Subjects with mild to moderate eczema; which will be determined using the Eichenfield Revised Criteria of Hannafin and Rajka at screening visit.
3. Judged by the Investigator to be in general good health on the basis of medical history.
4. Agree to use the Study-supplied investigational product as the only body cosmetic applied to irritated skin.
5. Agree to stop all dietary supplements including probiotics, dermatological medications and creams for eczema, during the entire length of the study
6. Agree not to change their current diet or exercise program during the entire study period.
7. Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
8. Females of child bearing potential must agree to use appropriate birth control methods during the entire study period.
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, hematologic, or biliary disorder.
b) Known allergy or sensitivity to Herbal products
c) Use of systemic corticosteroids in the past 30 days.
d) History of malignancy in the past two years.
e) Recent history of alcoholism (within 12 months) or strong potential for alcohol or substance abuse.
f) Participation in a clinical study with exposure to any non-registered drug product within 30 days prior.
g) Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, to comply with the study protocol or which might confound the interpretation of the study results or put the person at undue risk. Including subjects who are bed or wheelchair-bound.
h) Pregnant or lactating during the duration of the study.
i) Smoking – must be nonsmoker for at least 12 months prior to screening.

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 is by numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomized numbers
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
Statistical methods / analysis
SAS analysis using ANOVA/T-Test
The number of subjects was calculated based on the results of the first clinical trial for which we had 20 subjects resulting in clinical significance.
A power calculation was then carried out and for 80% powered the answer was 50 subjects. Because there is such a strong placebo effect with eczema, 50 was considered the bare minimum so we increased the number to 60 to ensure that we were indeed above a power calculation of 80%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/09/2015
Actual
13/09/2015
Date of last participant enrolment
Anticipated
31/12/2015
Actual
6/11/2015
Date of last data collection
Anticipated
Actual
2/02/2016
Sample size
Target
60
Accrual to date
Final
61
Recruitment outside Australia
Country [1] 7104 0
New Zealand
State/province [1] 7104 0

Funding & Sponsors
Funding source category [1] 291871 0
Commercial sector/Industry
Name [1] 291871 0
Decima Health Ltd
Country [1] 291871 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Decima Health Ltd
Address
6 Blake St
Rangiora,
Christchurch 7400
Country
New Zealand
Secondary sponsor category [1] 290535 0
None
Name [1] 290535 0
Address [1] 290535 0
Country [1] 290535 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293378 0
HDEC
Ethics committee address [1] 293378 0
Ethics committee country [1] 293378 0
New Zealand
Date submitted for ethics approval [1] 293378 0
Approval date [1] 293378 0
14/07/2015
Ethics approval number [1] 293378 0
15/NTA/89

Summary
Brief summary
This clinical trial is for testing a natural cream for relieving the symptoms of eczema
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59606 0
Dr Simon Carson
Address 59606 0
Southern Clinical Trials Group
6 Strickland St
Beckenham
Christchurch 8242
Country 59606 0
New Zealand
Phone 59606 0
+64 3 337 1979
Fax 59606 0
Email 59606 0
[email protected]
Contact person for public queries
Name 59607 0
Dr Simon Carson
Address 59607 0
Southern Clinical Trials Group
6 Strickland St
Beckenham
Christchurch 8242
Country 59607 0
New Zealand
Phone 59607 0
+64 3 337 1979
Fax 59607 0
Email 59607 0
[email protected]
Contact person for scientific queries
Name 59608 0
Dr Iona Weir
Address 59608 0
Decima Health Ltd,
6 Blake St
Rangiora
Christchurch 7400
Country 59608 0
New Zealand
Phone 59608 0
+64 21 309 084
Fax 59608 0
Email 59608 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

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