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Trial registered on ANZCTR


Registration number
ACTRN12612000257864
Ethics application status
Approved
Date submitted
28/02/2012
Date registered
1/03/2012
Date last updated
3/12/2020
Date data sharing statement initially provided
3/12/2020
Date results information initially provided
3/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of a menthol/ginseng mixture and its possible effects on pain responses in photodynamic therapy.
Scientific title
In patients receiving treatment for solar dermopathy with photodynamic therapy (PDT) does PDT-eze compared with no PDT-eze improve pain difference scores.
Secondary ID [1] 280050 0
Nil
Universal Trial Number (UTN)
U1111-1127-6634
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solar Dermopathy 285963 0
Condition category
Condition code
Skin 286148 286148 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284373 0
Treatment: Other
Comparator / control treatment
Placebo spray, topically administered to 1/2 of the face or 1/2 of the forearm (depending on whether patient is allocated to face or forearm group); 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.
Control group
Placebo

Outcomes
Primary outcome [1] 286621 0
Pain scores according to a verbally reported 1 to 10 scale
Timepoint [1] 286621 0
Measured immediately after illumination is complete, at 24hrs, and at 72 hours
Secondary outcome [1] 296291 0
Nil
Timepoint [1] 296291 0
Nil

Eligibility
Key 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
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Trial patients will be enrolled in the trial as either a ‘face or forearm’ subject according to the clinical assessment of solar dermopathy made by the study clinician at each trial centre. 1/2 face (left or right) and left or right forearms will then be randomised to receive topical application with PDT-eze (case) or placebo (controls) at the study control centre utilizing a validated computer based randomisation tool.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence for randomisation was generated via an internet randomisation generator via the following website:
http://www.randomization.com/

Available using seeds 1303 for forearm; 7323 for face.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/04/2012
Actual
2/04/2012
Date of last participant enrolment
Anticipated
Actual
15/04/2013
Date of last data collection
Anticipated
Actual
20/04/2013
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 5033 0
4216

Funding & Sponsors
Funding source category [1] 284802 0
Commercial sector/Industry
Name [1] 284802 0
Allmedic
Country [1] 284802 0
Australia
Funding source category [2] 284810 0
Self funded/Unfunded
Name [2] 284810 0
Peter Smith - Testudo Research Pty Ltd
Country [2] 284810 0
Australia
Primary sponsor type
Individual
Name
Peter Smith
Address
Pacific Private Clinic
Suite 4. Level 5, 123 Nerang Street
Southport, QLD 4215
Country
Australia
Secondary sponsor category [1] 283684 0
None
Name [1] 283684 0
Address [1] 283684 0
Country [1] 283684 0
Other collaborator category [1] 260575 0
Individual
Name [1] 260575 0
Dr Stuart Adamson
Address [1] 260575 0
5 Hermitage Street Geraldton 6530 WA
Country [1] 260575 0
Australia
Other collaborator category [2] 260576 0
Individual
Name [2] 260576 0
Dr Stephan Murray
Address [2] 260576 0
Capricorn Skin Centre, 287 Richardson Rd, Rockhampton 4700 Qld
Country [2] 260576 0
Australia
Other collaborator category [3] 260577 0
Individual
Name [3] 260577 0
Dr William Anseline
Address [3] 260577 0
20 Falkinda Ave, Paradise Point 4216, QLD
Country [3] 260577 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286791 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 286791 0
Office for research
Griffith University
G39 3.56
Gold Coast Campus
Parklands Drive
Southport, Qld 4215
Ethics committee country [1] 286791 0
Australia
Date submitted for ethics approval [1] 286791 0
Approval date [1] 286791 0
06/02/2012
Ethics approval number [1] 286791 0
MED/17/09/HREC

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33851 0
Prof Peter Smith
Address 33851 0
17/123 Nerang St Southport Qld 4215
Country 33851 0
Australia
Phone 33851 0
+61 915744
Fax 33851 0
Email 33851 0
[email protected]
Contact person for public queries
Name 17098 0
Peter Smith
Address 17098 0
Pacific Private Clinic
Suite 4. Level 5, 123 Nerang Street
Southport, QLD 4215
Australia
Country 17098 0
Australia
Phone 17098 0
+61 07 5591 5744
Fax 17098 0
Email 17098 0
[email protected]
Contact person for scientific queries
Name 8026 0
Peter Smith
Address 8026 0
Pacific Private Clinic
Suite 4. Level 5, 123 Nerang Street
Southport, QLD 4215
Australia
Country 8026 0
Australia
Phone 8026 0
+61 07 5591 5744
Fax 8026 0
Email 8026 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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Anseline W, Grose D, Smith P, Murray S, Messieh A,... [More Details]
Plain language summaryNo Use of a simple, plant derived anti-nociceptive sp... [More Details]

Documents added automatically
No additional documents have been identified.