Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000953538
Ethics application status
Approved
Date submitted
26/06/2024
Date registered
6/08/2024
Date last updated
6/08/2024
Date data sharing statement initially provided
6/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Whole body 360 Degree, 3-Dimensional skin imaging to document change in atopic dermatitis severity following treatment with dupilumab
Scientific title
Whole body 360 Degree, 3-Dimensional skin imaging to document change in atopic dermatitis severity following treatment with dupilumab in adult patients
Secondary ID [1] 312411 0
RS-SNFDPL-2021-10-22
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
 334222 0
Condition category
Condition code
Skin 330892 330892 0 0
Dermatological conditions

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will enroll 15 male and female patients, aged 18 years and above, who are diagnosed with moderate to severe chronic AD and who are candidates for systemic therapy or phototherapy. The decision to prescribe Dupilumab will be made by the treating doctor independently. Participation in the study primarily involves consenting to full-body photography and completion of the DLQI questionnaire. Treatment of patients will follow the Australian prescribing label.

Dupilumab (300mg/ml)
Trade name: Dupixent

Dupilumab is an interleukin-4 (IL-4) receptor alpha antagonist. It is a human monoclonal antibody of the immunoglobulin G4 subclass that inhibits IL-4 and interleukin-13 (IL-13) signaling by specifically binding to the IL-4 receptor alpha subunit, which is shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the type 1 receptor and both IL-4 and IL-13 signaling via the type 2 receptor. By blocking the IL-4R alpha subunit, Dupilumab inhibits IL-4 and IL-13 cytokine-induced responses, including the release of proinflammatory cytokines, chemokines, and immunoglobulin E alleviating AP symptoms.

This is an open-label, single-centre observational study looking at the photographic resolution of atopic dermatitis in patients receiving Dupilumab per standard regimen. 15 patients with moderate-to-severe chronic AD will be recruited. The decision to prescribe Dupilumab is made by the treating physician, prior to offering participation in this trial. Affected areas will be photographically mapped with whole body 3-D photography using Canfield Vectra WB360. Patients will take part for a maximum of 52 weeks in this study. The initial screening period is up to 4 weeks followed by scheduled visits at Baseline up to Week 52.

The study assessments include; Collecting patient demographics (date of birth, gender, ethnicity and child-bearing potential), Medical history, Concomitant treatment, physical examination, vital signs, whole-body photography, Eczema Area Severity Index, and Dermatology Life Quality Index.

All participants will be screened prior to enrolment in the study. The Baseline visit will occur no later than 28 days from Screening visit. Visits 3-10 must occur within 3 days from the scheduled dates based on the Baseline visit. Visits 11-14 must occur within 7 days from the scheduled dates based on the Baseline visit. For the end of study visit, a 7-day window applies based on the Baseline visit.

The decision to prescribe Dupilumab is made independently by the treating physician based on the patient's clinical needs, prior to any consideration of participation in this trial. Participants in this study will receive Dupilumab treatment irrespective of their involvement in the trial, and their decision to participate, discontinue participation, or discontinue Dupilumab treatment will not impact their access to standard medical care, including Dupilumab.

Enrollment in this observational study does not determine whether the participants receive Dupilumab; rather, it allows researchers to observe and collect data on the outcomes of Dupilumab treatment in a real-world setting. Therefore, participants would receive Dupilumab regardless of their involvement in the study, as it is prescribed independently of the study protocol and based solely on their medical requirements.
Intervention code [1] 328913 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338649 0
To document the incremental change in atopic dermatitis severity
Timepoint [1] 338649 0
Change in EASI scores will be assessed at every fortnightly visit from baseline to week 16, and then monthly from week 16 to week 52.
Primary outcome [2] 338728 0
To elucidate the pattern of resolution following treatment commencement with Dupilumab
Timepoint [2] 338728 0
The level of resolution will be assessed at every fortnightly visit from baseline to week 16, and then monthly from week 16 to week 52 by the investigator following image capture on the Canfield Vectra WB360.
Secondary outcome [1] 436838 0
To determine the impact of treatment with Dupilumab on quality of life
Timepoint [1] 436838 0
DLQI will be completed by participants at every fortnightly visit from baseline to week 16, and then monthly from week 16 to week 52.

Eligibility
Key inclusion criteria
Participants eligible for inclusion in the study must fulfil all the following criteria:

1. Male or female at least 18 years of age at time of screening.
2. Diagnosis of chronic atopic dermatitis for at least 6 months at Baseline.
3. Active atopic dermatitis present for at least 6 months from initial diagnosis
4. Ability to comprehend and willing to sign and date an informed consent form (ICF).
5. Adults who are eligible for systemic therapy or phototherapy.
6. Qualify for PBS-reimbursed Dupilumab. Moderate to severe atopic dermatitis as defined at study enrolment by:
i. PGA is equal to 4
ii. EASI score is greater than or equal to 20
iii. Documented inadequate response to topical corticosteroids or systemic immunosuppressants
7. The most recent documented EASI assessment must be no more than one month old at the time of starting the first dose of dupilumab
8. Naïve to biologics therapy for the treatment of chronic atopic dermatitis

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants fulfilling any of these criteria are not eligible for inclusion in this study:

1. Current treatment with systemic JAK inhibitor
2. Use of investigational treatments within 4 weeks before study assignment, or within a period of 5 half-lives of the investigational treatment, whichever is longer.
3. Previous exposure to other biologics agents such as but not limited to secukinumab, ustekinumab, brodalumab, ixikizumab, adalimumab, infliximab, briakinumab, efalizumab, golimumab, etanercept, tildrakizumab, apremilast, guselkumab and tofacitinib.
4. Diagnosis of other forms of inflammatory skin conditions eg psoriasis, lymphatic disease (EBV Virus), HIV, Hepatitis, Hep C, Shingles (disseminated), immunodeficiency disorders, malignancies, Tuberculosis, Thrombocytopenia, coagulopathy or platelet dysfunction.
5. Underlying health conditions (including but not limited to metabolic, cardiac, endocrine, neurologic, infectious and hepatic) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
6. History of infections within the last 6 months requiring hospitalization.
7. Pregnant or lactating women; Lactating (nursing) women will need to cease prior to commencing dupilumab. This will need to be discussed with the treating physician and/or the appropriate healthcare professional.
8. Receiving anti-coagulants.
9. Received a live or attenuated vaccine within 6 weeks of day 1 visit.
10. Recently undergone surgery or significant trauma.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/08/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316822 0
Self funded/Unfunded
Name [1] 316822 0
Dr Rodney Sinclair Pty Ltd
Country [1] 316822 0
Australia
Primary sponsor type
Individual
Name
Dr Rodney Sinclair Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319053 0
None
Name [1] 319053 0
Address [1] 319053 0
Country [1] 319053 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315592 0
Bellberry Human Research Ethics Committee K
Ethics committee address [1] 315592 0
https://bellberry.com.au/
Ethics committee country [1] 315592 0
Australia
Date submitted for ethics approval [1] 315592 0
15/04/2024
Approval date [1] 315592 0
11/07/2024
Ethics approval number [1] 315592 0

Summary
Brief summary
This is an open-label, single-centre observational study looking at the photographic resolution of atopic dermatitis in patients receiving Dupilumab per standard regimen. Patients will be photographed fortnightly from baseline to week 16, and then monthly from week 16 to week 52.

15 patients with moderate-to-severe chronic Atopic Dermatitis will be recruited. The decision to prescribe Dupilumab is made by the treating physician, prior to offering participation in this trial. Affected areas will be photographically mapped with whole body 3-D photography using Canfield Vectra WB360.

Patients will take part for a maximum of 52 weeks in this study. The initial screening period is up to 4 weeks followed by scheduled visits at Week 0 (Baseline) and fortnightly visits up to Week 52.

It is hypothesized that treatment with Dupilumab will lead to a statistically significant improvement in atopic dermatitis severity, as measured by the Eczema Area and Severity Index (EASI), and will correlate positively with improvements in quality of life, as assessed by the Dermatology Life Quality Index (DLQI), over the course of 52 weeks
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135174 0
Prof Rodney Sinclair
Address 135174 0
Dr Rodney Sinclair Pty Ltd: Level 3, 2 Wellington Parade East Melbourne, VIC 3002
Country 135174 0
Australia
Phone 135174 0
+61 3 9013 0099
Fax 135174 0
Email 135174 0
[email protected]
Contact person for public queries
Name 135175 0
Laita Bokhari
Address 135175 0
Dr Rodney Sinclair Pty Ltd: Level 3, 2 Wellington Parade East Melbourne, VIC 3002
Country 135175 0
Australia
Phone 135175 0
+61 3 9013 0099
Fax 135175 0
Email 135175 0
[email protected]
Contact person for scientific queries
Name 135176 0
Laita Bokhari
Address 135176 0
Dr Rodney Sinclair Pty Ltd: Level 3, 2 Wellington Parade East Melbourne, VIC 3002
Country 135176 0
Australia
Phone 135176 0
+61 3 9013 0099
Fax 135176 0
Email 135176 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.