Whole body 360 Degree, 3-Dimensional skin imaging to document change in atopic dermatitis severity following treatment with dupilumab
- Conditions
- Atopic DermatitisSkin - Dermatological conditions
- Registration Number
- ACTRN12624000953538
- Lead Sponsor
- Dr Rodney Sinclair Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 15
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
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
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To document the incremental change in atopic dermatitis severity [Assessed through photographic analysis and using EASI (Eczema Area and Severity Index) scoring from Baseline to Week 52 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.];To elucidate the pattern of resolution following treatment commencement with Dupilumab [Assess the resolution in atopic dermatitis severity through photographic analysis with the Canfield Vectra WB360 whole body surface imaging system and EASI (Eczema Area and Severity Index) score from Baseline to Week 52. <br><br>The photographic analyses and EASI scores will be assessed together. 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 Measures
Name Time Method To determine the impact of treatment with Dupilumab on quality of life [Change in DLQI (Dermatology Life Quality Index) score DLQI will be completed by participants at every fortnightly visit from baseline to week 16, and then monthly from week 16 to week 52.]