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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
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.
Secondary ID [1] 299621 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AD-2019
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psoriasis 314925 0
atopic dermatitis (eczema) 314926 0
Condition category
Condition code
Skin 313281 313281 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 315878 0
Treatment: Drugs
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.
Control group
Placebo

Outcomes
Primary outcome [1] 321769 0
Percentage change in local eczema area and severity index (L-EASI) or psoriasis area and severity index (PASI)
Timepoint [1] 321769 0
Day 60
Secondary outcome [1] 376159 0
Percentage change from baseline in Investigator's Global Assessment (IGA) score for psoriasis or atopic dermatitis
Timepoint [1] 376159 0
Day 30 and Day 60
Secondary outcome [2] 376160 0
Percentage change from baseline in local pruritus score, assessed using a visual analogue scale (VAS)
Timepoint [2] 376160 0
Day 30 and Day 60
Secondary outcome [3] 376617 0
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
Timepoint [3] 376617 0
Day 30 and 60

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.
Minimum age
9 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/01/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15036 0
St George Dermatology & Skin Cancer Centre - Kograh
Recruitment postcode(s) [1] 28320 0
2217 - Kograh

Funding & Sponsors
Funding source category [1] 304098 0
Commercial sector/Industry
Name [1] 304098 0
GNP Australia
Country [1] 304098 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GNP Australia
Address
28-30 Harris Road
Dural NSW 2158
Country
Australia
Secondary sponsor category [1] 304308 0
None
Name [1] 304308 0
Address [1] 304308 0
Country [1] 304308 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304587 0
Bellberry
Ethics committee address [1] 304587 0
Ethics committee country [1] 304587 0
Australia
Date submitted for ethics approval [1] 304587 0
23/07/2019
Approval date [1] 304587 0
Ethics approval number [1] 304587 0

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

Contacts
Principal investigator
Name 97490 0
A/Prof Stephen Shumack
Address 97490 0
St George Dermatology and Skin Cancer Centre
3/22 Belgrave Street
Kogarah NSW 2217
Country 97490 0
Australia
Phone 97490 0
+61295874277
Fax 97490 0
Email 97490 0
[email protected]
Contact person for public queries
Name 97491 0
Stephanie Blake
Address 97491 0
St George Dermatology and Skin Cancer Centre
3/22 Belgrave Street
Kogarah NSW 2217
Country 97491 0
Australia
Phone 97491 0
+61295874277
Fax 97491 0
Email 97491 0
[email protected]
Contact person for scientific queries
Name 97492 0
Iraj Ghadiminejad
Address 97492 0
GNP Australia
28-30 Harris Road
Dural NSW 2158
Country 97492 0
Australia
Phone 97492 0
+612 9011 8006
Fax 97492 0
Email 97492 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


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.