None listed
Conditions
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).
Interventions
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.
Sponsors
The University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed