None listed
Conditions
Brief summary
A prospective randomised controlled study is to be conducted over 3 separate clinics to determine efficacy of PDT eze (a topically applied, naturally occurring pain receptor blocker) in managing sensory components, such as pain and discomfort, in relation to photodynamic therapy (PDT) and other causes of inflammation. The study will examine patients receiving treatment for solar dermopathy with photodynamic therapy (PDT) utilizing standardized protocols with 5 amino-levulinic acid (5ALA). Differences in both acute and late phase pain and inflammation will be measured. PDT eze and a placebo spray will be used on split body treatment, either arm or face, and therefore the participants are their own control. There will be 10 patients for each treatment area in each individual clinic, with a total of 60 participants included. PDT eze and the placebo will be applied via a spray prior to treatment with PDT. Both will be applied to each participant in a split body application. Application of active and placebo treatments will be randomized and only known to clinician administering. Participants will be asked to give pain scores for both treatment areas on a scale of 1-10 following illumination. These will be recorded and compared to other participants ratings to determine whether PDT eze has an effect on the pain and discomfort experienced during inflammation caused by PDT.
Interventions
PDT-eze (a spray made up of naturally derived actives menthol/ginseng) topically administered 2-4 sprays to 1/2 face or 1/2 forearm (whether applied to face or forearm will be determined on clinical evaluation of severity of solar dermopathy in these areas, with clinician selecting most severe area for treatment) 10 minutes prior to onset of illumination and further 2-4 sprays at any time during the course of illumination that is requested by the subject – ensuring no cross contamination betwe
PDT-eze (a spray made up of naturally derived actives menthol/ginseng) topically administered 2-4 sprays to 1/2 face or 1/2 forearm (whether applied to face or forearm will be determined on clinical evaluation of severity of solar dermopathy in these areas, with clinician selecting most severe area for treatment) 10 minutes prior to onset of illumination and further 2-4 sprays at any time during the course of illumination that is requested by the subject – ensuring no cross contamination between each side of face or forearm. Illumination shall comprise 20minutes of blue light at 470nm followed by 10minutes of red light at 640nm using a TGA approved light source.
Sponsors
Peter Smith
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients male or female older than 21 with mild to moderate solar dermopathy of their face or forearms in whom the managing clinician feels photodynamic therapy to be an appropriate treatment modality * Must have indicated a willingness to enter the study * Must have read and fully understood a study information form * Must have had the opportunity to ask any questions prior to enrolment * Must have signed study consent form
Exclusion criteria
* Any contraindications to PDT * Having received PDT to the treatment area in the last 2years * Any history of reaction or intolerance to menthol/ginseng mixture or the standard PDT preparation and treatment formulations - alpha hydroxy acid preparations at 10 and 15%. * Any obvious cutaneous malignancies in the area to receive PDT (these must be appropriately managed before consideration of enrolment in the trial) * Pregnancy
Outcome results
None listed