Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001716853
Ethics application status
Approved
Date submitted
17/11/2021
Date registered
16/12/2021
Date last updated
9/03/2022
Date data sharing statement initially provided
16/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of photos with in-clinic assessment of atopic dermatitis and psoriasis severity
Scientific title
Comparison of 3D Total Body Imaging and smartphone photos with in-clinic assessment of atopic dermatitis and psoriasis severity
Secondary ID [1] 305589 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psoriasis 324007 0
atopic dermatitis 324008 0
eczema 324009 0
Condition category
Condition code
Skin 321516 321516 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
Participants who have atopic dermatitis or psoriasis will be asked to visit the study researchers for two in-person visits at the Princess Alexandra Hospital (Brisbane), approximately three months apart. At the first in-person visit we will obtain informed consent and administer a short demographics survey. Participants will be imaged using the VECTRA whole-body scanner (VECTRA WB360 Serial Number WB00009, Canfield Scientific Inc, Parsippany, NJ, USA), to conduct 3D total body photography to assess the severity of psoriasis and acute dermatitis at both visits.

Two study doctors will also independently provide an in-person whole body clinical consultation of the participants skin condition severity at each visit. Each visit will take approximately 90 minutes.

After both in-person visits participants will be asked to photograph their skin condition using their own smartphone camera at home using the study app and instructions provided by the research team (may be completed up to 48 hours after the visit). At the end of the study participants will be asked to complete an online survey on their experience in the study and the technologies used.

Participants will not receive any feedback or medical advice throughout the study. Throughout the study, participants are advised to follow their usual treatment regime as prescribed by their own doctors.
Intervention code [1] 321986 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329285 0
To investigate the level of agreement between severity assessments obtained in-clinic with remote severity assessments from 3D total-body photography and smartphone photos.
Timepoint [1] 329285 0
Baseline (visit 1 ) and 3 months (visit 2)
Secondary outcome [1] 402018 0
To assess intra- and inter-assessor reliability between clinicians
Timepoint [1] 402018 0
Baseline (visit 1) and 3 months (visit 2)
Secondary outcome [2] 402019 0
To examine the ability of remote assessments to detect change over time. Change over time will be assessed by the study doctors using validated questionnaire scoring tools (Psoriasis Area and Severity Index (PASI), Physician's Global Assessment score, SCORAD (Scoring Atopic Dermatitis), The Eczema Area and Severity Index (EASI), The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) across the two separate timepoints.
Timepoint [2] 402019 0
Baseline (visit 1) and 3 months (visit 2)
Secondary outcome [3] 403776 0
To assess participants' satisfaction with the imaging process
Timepoint [3] 403776 0
online survey at home after visit 2 (3 months)

Eligibility
Key inclusion criteria
Participants 18 years of age or older with diagnosed atopic dermatitis or psoriasis, with visible lesions on non-private body areas; willing to be imaged.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No other exclusion criteria, apart from opposite of the inclusion criteria.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20803 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 35622 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 309954 0
Government body
Name [1] 309954 0
AusIndustry Funded Collaboration between the University of Queensland, Leo Pharma and Studies&Me
Country [1] 309954 0
Australia
Funding source category [2] 310179 0
Commercial sector/Industry
Name [2] 310179 0
Studies&Me (LeoPharma)
Country [2] 310179 0
Denmark
Primary sponsor type
University
Name
University of Queensland
Address
The University of Queensland,
Building 33,
Princess Alexandra Hospital
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 310995 0
None
Name [1] 310995 0
Address [1] 310995 0
Country [1] 310995 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309669 0
Metro South Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 309669 0
Ethics committee country [1] 309669 0
Australia
Date submitted for ethics approval [1] 309669 0
19/08/2021
Approval date [1] 309669 0
23/11/2021
Ethics approval number [1] 309669 0

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

Contacts
Principal investigator
Name 114974 0
Prof H. Peter Soyer
Address 114974 0
The University of Queensland Diamantina Institute
Translational Research Institute
37 Kent Street
Woolloongabba, QLD 4102
Country 114974 0
Australia
Phone 114974 0
+61 07 3443 8017
Fax 114974 0
Email 114974 0
p.soyer@uq.edu.au
Contact person for public queries
Name 114975 0
Monika Janda
Address 114975 0
Princess Alexandra Hospital
Centre for Health Services Research
Princess Alexandra Hospital
199 Ipswich Rd,
Woolloongabba QLD 4102
Country 114975 0
Australia
Phone 114975 0
+61 07 3176 4569
Fax 114975 0
Email 114975 0
m.janda@uq.edu.au
Contact person for scientific queries
Name 114976 0
Monika Janda
Address 114976 0
Princess Alexandra Hospital
Centre for Health Services Research
199 Ipswich Rd,
Woolloongabba QLD 4102
Country 114976 0
Australia
Phone 114976 0
+61 07 3176 4569
Fax 114976 0
Email 114976 0
m.janda@uq.edu.au

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.