Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001207202
Ethics application status
Approved
Date submitted
27/06/2018
Date registered
18/07/2018
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
feasibility of Innovative photography technology (The VISIA facial imaging system) to monitor the effect of 5-flurouracil treatment for people with solar/actinic damage to their face.
Scientific title
High-definition, high-resolution photography trending 5-flurouracil treatment for facial solar damage – an Australian prospective trial.
Secondary ID [1] 295307 0
HPS005
Universal Trial Number (UTN)
U1111-1216-2102
Trial acronym
VISIA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
facial solar (actinic) damage 308528 0
Condition category
Condition code
Skin 307497 307497 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients under the care of specialist dermatologists at the Princess Alexandra Hospital, who require topical field therapy for solar facial damage, and the clinician deems 5-fluroruracil the treatment of choice, will be observed using the VISIA Deluxe Imaging System (facial photography device), before, during and after treatment.
After commencing treatment, follow up visits will be at 2 weeks, then 4-6 weeks, and lastly at 12 weeks.
Intervention code [1] 301654 0
Early detection / Screening
Comparator / control treatment
there is no comparator/control in this trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306469 0
Assess the suitability of the VISIA Deluxe Imaging System to measure signs of photo damage/photo-aging in patients undergoing treatment with 5-fluroruracil for actinic/solar damage to the scalp/face.
This is done by comparing statistical significance testing of quantitative scoring provided by the VISIA, compared to clinical examination of participants skin, e.g. assessing surface scale and keratin, and presence of dermoscopic characteristics e.g. rosettes and strawberry pattern.
Timepoint [1] 306469 0
2 weeks post commencing treatment
Secondary outcome [1] 348632 0
Assess the suitability of the VISIA Deluxe Imaging System to measure signs of photo damage/photo-aging in patients undergoing treatment with 5-fluroruracil for actinic/solar damage to the scalp/face.
This is done by comparing statistical significance testing of quantitative scoring provided by the VISIA, compared to clinical examination of participants skin, e.g. assessing surface scale and keratin, and presence of dermoscopic characteristics e.g. rosettes and strawberry pattern.
Timepoint [1] 348632 0
at 4-6 weeks post treatment and 12 weeks post treatment

Eligibility
Key inclusion criteria
over the age of 18 years old, able to give informed consent, and about to commence 5-flurouracil treatment to face/scalp for solar/actinic damage to their skin.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that have had field-treatment with 5-flurouracil, imiquimod, diclofenac sodium, ingenol mebutate or PDT within the last 12months or those who have periodically spot-treat keratinocyte lesions under the care of their dermatologist or GP within the last 12-months. Patients who would normally carry-out follow-up with their GP (for any reason including rural/remote home address, limited mobility etc.) will also be excluded in the interests of having standardised follow-up for study participants. Should at any time during the study period the clinician elect to cease treatment or perform alternate treatment (e.g. surgical) the participant will be excluded.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is exploratory research, the sample size is not based on statistical data, and statistical methods of analysis are not defined for the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/06/2018
Date of last participant enrolment
Anticipated
24/06/2019
Actual
6/03/2019
Date of last data collection
Anticipated
23/09/2019
Actual
5/06/2019
Sample size
Target
50
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11241 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 23114 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 299896 0
University
Name [1] 299896 0
The University of Queensland
Country [1] 299896 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The Dermatology Research Centre
Level 5, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4053
Country
Australia
Secondary sponsor category [1] 299286 0
None
Name [1] 299286 0
Address [1] 299286 0
Country [1] 299286 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300766 0
Metro South Human Research Ethics Committee [EC00167]
Ethics committee address [1] 300766 0
Translational Research Institute, Level 7
37 Kent Street
Woolloongabba QLD 4053
Ethics committee country [1] 300766 0
Australia
Date submitted for ethics approval [1] 300766 0
07/05/2018
Approval date [1] 300766 0
15/05/2018
Ethics approval number [1] 300766 0
HREC/18/QPAH/276

Summary
Brief summary
Patients already under the care of specialist dermatologists or referred to a dermatologist at The Princess Alexandra Hospital will be recruited during attendance for their full skin examination. Should a patient require topical field therapy and the clinician deems 5-fluroruracil the treatment of choice – the patient’s usual doctor or nurse will introduce the study to their patient and gauge their interest in participating.
A member of the study team will be available to answer any questions or concerns a patient may have regarding the trial, before ensuring informed consent is granted. The member of the study team will also record information on demographic, and relevant medical history from the patient, as listed below. Baseline clinical photographs will be taken using the specialised facial photography machine (VISIA®, Canfield Scientific).
Once enrolled, patients will be flagged by the study team and followed at their subsequent reviews. As part of standard care, patients are requested to present for review at 2weeks after commencing treatment and again at the conclusion of treatment (4 or 6 weeks depending on indication). Patients are also requested to present 12weeks after the commencement of treatment for final evaluation. At any stage, but particularly at 12weeks after commencement of treatment – careful examination is performed to determine of any field-treatment failures so that subsequent management may be initiated (e.g. formal excision).
At the conclusion of their usual clinical follow-up appointment, the participant will be ushered into the adjunct research room for repeat/progress specialised facial photography as described above (VISIA®, Canfield Scientific).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84742 0
Prof H. Peter Soyer
Address 84742 0
Dermatology Research Centre,
Translational Research Institute, Level 5
37 Kent Street
Woolloongabba QLD 4053
Country 84742 0
Australia
Phone 84742 0
+61 07 3443 8017
Fax 84742 0
Email 84742 0
[email protected]
Contact person for public queries
Name 84743 0
Clare Primiero
Address 84743 0
Dermatology Research Centre,
Translational Research Institute, Level 5
37 Kent Street
Woolloongabba QLD 4053
Country 84743 0
Australia
Phone 84743 0
+61 07 3443 7496
Fax 84743 0
Email 84743 0
[email protected]
Contact person for scientific queries
Name 84744 0
Clare Primiero
Address 84744 0
Dermatology Research Centre,
Translational Research Institute, Level 5
37 Kent Street
Woolloongabba QLD 4053
Country 84744 0
Australia
Phone 84744 0
+61 07 3443 7496
Fax 84744 0
Email 84744 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5812Study protocol  [email protected]
5813Informed consent form  [email protected]
5814Ethical approval  [email protected]



Results publications and other study-related documents

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