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Whole body 360 Degree, 3-Dimensional skin imaging to document change in atopic dermatitis severity following treatment with dupilumab

Whole body 360 Degree, 3-Dimensional skin imaging to document change in atopic dermatitis severity following treatment with dupilumab in adult patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624000953538
Enrollment
15
Registered
2024-08-06
Start date
2024-08-16
Completion date
2025-07-01
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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 n

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.

Sponsors

Dr Rodney Sinclair Pty Ltd
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026