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Trial registered on ANZCTR
Registration number
ACTRN12619001536156p
Ethics application status
Submitted, not yet approved
Date submitted
23/10/2019
Date registered
7/11/2019
Date last updated
7/11/2019
Date data sharing statement initially provided
7/11/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Assessing the effectiveness of ENDOR combination therapy in atopic dermatitis (eczema) and psoriasis patients
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Scientific title
Combination of ENDOR Dermatitis Care Oral Capsules and a Topical ENDOR Cream Therapy to Treat Moderate Atopic Dermatitis and Psoriasis in Participants Aged 9 – 65 years: A Randomised, Double-Blind Placebo-Controlled Trial.
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Secondary ID [1]
299621
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
AD-2019
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
psoriasis
314925
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atopic dermatitis (eczema)
314926
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Condition category
Condition code
Skin
313281
313281
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0
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Dermatological conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
ENDOR Combination therapy - ENDOR Dermatitis Care capsules and ENDOR 3.5 topical cream.
Treatment phase dosing occurs from Day 0 up to Day 30, when participants aged 16 – 65 years old will take four capsules per day, two in the morning and two at night, and those aged 9 – 15 years take two capsules per day, one in the morning and one at night. The participants concomitantly topically apply at least 3g of the study cream, twice daily. The recommendation application amount is 2g of cream to a treatment area the size of the participants hand span. Participants will be shown the amount they need to apply at their initial study visit. There is no maximal dose for the ENDOR cream, however patients with extensive disease will not be eligible for the study (moderate severity only).
After the initial 30 days, the participants enter the maintenance phase where participants aged 16- 65 years take two capsules per day, one in the morning and one at night, and participants aged 9-15 years take one capsule per day. The maintenance phase will begin at Day 30 and end on Day 60. Participants will continue to apply the ENDOR cream to affected areas, using 2g/area the size of the participants hand span, until the lesions resolve.
Participants will be required to return all used and unused medication to the trial site for compliance monitoring.
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Intervention code [1]
315878
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Treatment: Drugs
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Comparator / control treatment
20% of participants will be randomised to placebo. The placebo cream is ENDOR 3.5 cream, without oleic acid and the placebo capsules are cellulose filled capsules, made by a compounding pharmacy to look identical to the ENDOR Dermatitis Care Capsules.
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Control group
Placebo
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Outcomes
Primary outcome [1]
321769
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Percentage change in local eczema area and severity index (L-EASI) or psoriasis area and severity index (PASI)
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Assessment method [1]
321769
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Timepoint [1]
321769
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Day 60
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Secondary outcome [1]
376159
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Percentage change from baseline in Investigator's Global Assessment (IGA) score for psoriasis or atopic dermatitis
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Assessment method [1]
376159
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Timepoint [1]
376159
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Day 30 and Day 60
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Secondary outcome [2]
376160
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Percentage change from baseline in local pruritus score, assessed using a visual analogue scale (VAS)
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Assessment method [2]
376160
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Timepoint [2]
376160
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Day 30 and Day 60
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Secondary outcome [3]
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Adverse events - using patient self reports, local skin irritation assessment and general clinical examination
Potential AEs - irritation at application site and potential flare of atopic dermatitis and psoriasis in the placebo arm
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Assessment method [3]
376617
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Timepoint [3]
376617
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Day 30 and 60
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Eligibility
Key inclusion criteria
1. Males or females aged 9 – 65 years at the time of screening.
2. Individuals diagnosed with atopic dermatitis as per Hanifin and Rajka criteria and confirmed by a dermatologist, or psoriasis (diagnosed by a qualified dermatologist)
3. Individuals with moderate atopic dermatitis (defined as EASI 10 – 16) or moderate psoriasis (defined as PASI 10-16).
4. Have a target lesion of atopic dermatitis or psoriasis, measuring between 25 cm2 and 70 cm2 within an area of 130 cm2 (based on diagnosis by a suitably qualified Investigator).
5. Be able to provide written informed consent prior to the performance of any study specific procedures.
6. Duration of atopic dermatitis or psoriasis of at least six months, with stable disease in both extent and severity, for at least two weeks prior to the commencement of study treatment.
7. Willing and able to comply with all study assessments and adhere to the protocol schedule.
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Minimum age
9
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Participants with >25% affected body surface area of atopic dermatitis or psoriasis on the face, palms or soles
2. Participants with any skin condition other than atopic dermatitis or psoriasis; in particular cutaneous infections, significant sun damage or an inherited skin disorder, that in the opinion of the Investigator could interfere with the evaluation of the trial medication.
3. History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations.
4. Treatment with any of the following within 4 weeks prior to the commencement of study treatment or during the study:
a. Systemic retinoids
b. Oral immunosuppressant medications such as methotrexate, cyclosporine, azathioprine, thioguanineprednisone, prednisolone, hydroxyurea, or mycophenolate mofetil
b. Oral or topical antibiotics
c. Phototherapy or photochemotherapy
d. High potency topical corticosteroids
e. Alternative medicine treatments
f. Significant sun exposure or tanning bed use
g. Any other therapy that in the opinion of the Investigator could modify disease activity.
5. Treatment with any of the following within 2 weeks prior to commencement of study treatment and during the study:
a. Weak to moderate potency topical corticosteroids
b. Topical retinoids
c. Topical keratolytics, coal tar or dithranol
d. Any other topical agent that in the opinion of the Investigator could modify disease activity.
6. Have received any investigational research agent or therapeutic biologic within 30 days or five half-lives (whichever is longer) prior to the first dose of IP.
7. Have clinical signs of active infection and/or a temperature of >38.0°C at the time of screening. Study entry may be deferred at the discretion of the Principal Investigator.
8. Have major surgery planned within the trial period.
9. Participants who are unable to sign consent or unable to return for all scheduled study visits.
10. Patients who are currently pregnant or breast-feeding, or planning to fall pregnant/breast-feed during the trial
11. Has any condition that, in the opinion of the Investigator, would make participation not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be assigned a randomisation number by an independent biostatistican, and this will correspond to a batch of ENDOR combination therapy products to be dispensed by site staff.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Efficacy: Treatment effect comparison between ENDOR products and placebo products will be analysed by an Analysis of Covariance (ANCOVA) model, with baseline PASI or EASI value at Day 0 prior to IP dosing, sex and treatment included as predictors. The least-squares mean of each treatment group, 95% confidence interval, and the difference between treatment groups will be estimated based on the ANCOVA. If the data is not normally distributed, a sensitivity analysis and nonparametric Wilcoxon Rank-Sum test will be used to compare treatment effect between ENDOR™ and placebo.
No multiplicity will be adjusted.
Demographics: The demographic variables such as age, race, etc. and baseline status (medical history, physical exam, disease and treatment history, etc.) will be summarised and presented as overall data.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
13/01/2020
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
15036
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St George Dermatology & Skin Cancer Centre - Kograh
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Recruitment postcode(s) [1]
28320
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2217 - Kograh
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Funding & Sponsors
Funding source category [1]
304098
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Commercial sector/Industry
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Name [1]
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GNP Australia
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Address [1]
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28-30 Harris Road
Dural NSW 2158
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Country [1]
304098
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
GNP Australia
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Address
28-30 Harris Road
Dural NSW 2158
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Country
Australia
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Secondary sponsor category [1]
304308
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None
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Name [1]
304308
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Address [1]
304308
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Country [1]
304308
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
304587
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Bellberry
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Ethics committee address [1]
304587
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123 Glen Osmond Road
Eastwood SA 5063
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Ethics committee country [1]
304587
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Australia
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Date submitted for ethics approval [1]
304587
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23/07/2019
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Approval date [1]
304587
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Ethics approval number [1]
304587
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Summary
Brief summary
ENDOR combination therapy is a natural alternative to steroid use, in the treatment of eczema and psoriasis. ENDOR Dermatitis Care Capsules contain multivitamins and other natural anti-inflammatory ingredients such as curcumin and ENDOR 3.5 cream is a soothing, moisturizing cream.
This clinical trial will assess the effectiveness and safety of ENDOR Combination Therapy (ENDOR 3.5 cream and ENDOR Dermatitis Care Capsules) in treating moderate atopic dermatitis or psoriasis. A total of 60 participants will be recruited, and will use ENDOR Combination Therapy for sixty days. During the study, site personnel will assess their skin conditions, take progress photographs and administer questionnaires to assess quality of life. 20% of participants will be allocated to the placebo arm, and will be receiving dummy treatment. These patients will be offered the opportunity to trial ENDOR Combination Therapy at the end of the study if interested.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Stephen Shumack
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Address
97490
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St George Dermatology and Skin Cancer Centre
3/22 Belgrave Street
Kogarah NSW 2217
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Country
97490
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Australia
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Phone
97490
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+61295874277
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Fax
97490
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Email
97490
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[email protected]
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Contact person for public queries
Name
97491
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Dr Stephanie Blake
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Address
97491
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St George Dermatology and Skin Cancer Centre
3/22 Belgrave Street
Kogarah NSW 2217
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Country
97491
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Australia
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Phone
97491
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+61295874277
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Fax
97491
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Email
97491
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[email protected]
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Contact person for scientific queries
Name
97492
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Dr Iraj Ghadiminejad
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Address
97492
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GNP Australia
28-30 Harris Road
Dural NSW 2158
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Country
97492
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Australia
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Phone
97492
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+612 9011 8006
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Fax
97492
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Email
97492
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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