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Trial registered on ANZCTR


Registration number
ACTRN12613000319774
Ethics application status
Not yet submitted
Date submitted
14/03/2013
Date registered
21/03/2013
Date last updated
21/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The assessment of local response to topical menthol gel and capsaicin gel applied with and without microneedle pretreatment
Scientific title
The assessment of local response to topical menthol gel and capsaicin gel applied with and without microneedle pretreatment on the forearm skin of 60 healthy adult volunteers
Secondary ID [1] 282130 0
none
Universal Trial Number (UTN)
U1111-1140-6112
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
local pain sensitivity 288627 0
Condition category
Condition code
Skin 288961 288961 0 0
Normal skin development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
60 pain-free subjects (18-65), voluntarily by poster / Curtin radio adverts
Separate study for menthol and capsaicin (30 subjects in each)

Menthol gel protocol:
Repeated measures design:
1.Microneedle pretreatment or dummy procedure will be applied to test area on forearm of the volunteer. Microneedle pretreatment involves pressing the microneedle array firmly onto the skin for a 10 second period. Microneedles have recently become commercially available, for example with the 3M MicrochannelTM Skin System (3M, St Paul, MN). This comprises an array of pyramidal-shaped needles approximately 700 micrometer in height with tip-to-tip needle spacing of approximately 500 micrometer that penetrate 100-150 micrometer into the epidermis. The microneedle pretreatment or dummy procedure will be applied to the skin with each volunteer receiving both treatment and dummy procedure over the two test days. Drug gel treatment will be the same on each test day. Dummy microneedles look the same as the microneedle array but the points of the needles have been blunted so that they do not penetrate the skin.
2.TiVi measurement of skin colour (erythema) will be recorded prior to and immediately after microneedle pretreatment
3.Two grams of 15% menthol in a hydroalcoholic gel will then be applied and occluded by a Tegaderm dressing for a total period of 15 minutes.
4.The gel will be wiped off the skin with a damp cloth and the area dried gently
5.TiVi measurements will be resumed for 15 min following removal of the gel.
The approximate duration of each session is 30 mins, washout period is 7 days.

The protocol above will be repeated for 2g of 0.025% capsaicin in a hydroalcoholic gel.
Intervention code [1] 286734 0
Treatment: Devices
Intervention code [2] 286752 0
Treatment: Drugs
Comparator / control treatment
Comparator treatment will involve a dummy microneedle application followed by either menthol gel or capsaicin gel. The dummy microneedles look identical to the microneedle array but the points of the needles have been blunted so that they do not penetrate the skin.

This will be pressed onto the skin with equal force to the real micro needles and for the same duration. The applicator will look similar.
Control group
Placebo

Outcomes
Primary outcome [1] 289090 0
faster onset time of effect of the drug treatment due to the micro needle pretreatment of the skin
Timepoint [1] 289090 0
The time to maximum effect measured by visual analogue scale and TiVi units of erythema. Visual analogue scale measurements will be recorded every minute and TiVi unit measurements are taken every 20 seconds over the 15 minute period the gel is on the skin. In addition TiVi measurements will be continued for 15 minutes after gel removal (30 minutes in total).
Primary outcome [2] 289122 0
Increased effect of drug treatment due to microneedle pretreatment of the skin.
Visual analogue scale measurements will be recorded every minute and TiVi unit measurements are taken every 20 seconds over the 15 minute period the gel is on the skin. In addition TiVi measurements will be continued for 30 minutes after gel removal.
Timepoint [2] 289122 0
Maximum effect measured by visual analogue scale and TiVi units of erythema.
Visual analogue scale measurements will be recorded every minute and TiVi unit measurements are taken every 20 seconds over the 15 minute period the gel is on the skin. In addition TiVi measurements will be continued for 15 minutes after gel removal.
Secondary outcome [1] 301744 0
Increased blood flow in the area of application will be assessed by the TiVi system which uses a camera and image analysis of the redness on the skin surface.
Timepoint [1] 301744 0
TiVi unit measurements are taken every 20 seconds over the 15 minute period the gel is on the skin. In addition TiVi measurements will be continued for 15 minutes after gel removal.
Secondary outcome [2] 301872 0
Sensation is assessed by Visual Analogue scale by the volunteers during the drug treatment. Visual Analogue scale measures will be taken every minute during gel application.
Timepoint [2] 301872 0
Visual Analogue scale measures will be taken every minute during gel application.

Eligibility
Key inclusion criteria
healthy skin, without any underlying comorbidities, or known allergies to menthol or capsaicin.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
history of asthma, allergic rhinitis or atopy, or skin irritation with topical products containing menthol or capsaicin, or allergic skin reactions to topical substances; broken skin or recent tattoo at the treatment site. The previous topical menthol study suggested that the anti-acne drug Roaccutane may amplify response to menthol so is now also an exclusion criteria. Subjects’ forearm skin will be checked for redness or signs of reaction between applications and subjects allowed to withdraw from further test sessions if a significant skin irritation lasts longer than 2 hours (visual or sensory effect). Note that the gels will be applied under occlusion therefore risk of inhalation of menthol or capsaicin is reduced.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each subject will act as their own control but will not be aware of active or placebo treatment on each study period. Microneedles or dummy microneedles (look the same but have the needle points blunted) will be applied prior to the drug treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Phase 0
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 6582 0
6845 - Perth

Funding & Sponsors
Funding source category [1] 286897 0
University
Name [1] 286897 0
Curtin University
Country [1] 286897 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth
WA 6845
Country
Australia
Secondary sponsor category [1] 285684 0
None
Name [1] 285684 0
Address [1] 285684 0
Country [1] 285684 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288957 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 288957 0
Ethics committee country [1] 288957 0
Australia
Date submitted for ethics approval [1] 288957 0
12/02/2013
Approval date [1] 288957 0
Ethics approval number [1] 288957 0
4425

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

Contacts
Principal investigator
Name 38514 0
A/Prof Heather Benson
Address 38514 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth
WA 6845
Country 38514 0
Australia
Phone 38514 0
+61 8 92662338
Fax 38514 0
Email 38514 0
h.benson@curtin.edu.au
Contact person for public queries
Name 38515 0
Heather Benson
Address 38515 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth
WA 6845
Country 38515 0
Australia
Phone 38515 0
+61 8 92662338
Fax 38515 0
Email 38515 0
h.benson@curtin.edu.au
Contact person for scientific queries
Name 38516 0
Heather Benson
Address 38516 0
School of Pharmacy
Curtin University
GPO Box U1987
Perth
WA 6845
Country 38516 0
Australia
Phone 38516 0
+61 8 92662338
Fax 38516 0
Email 38516 0
h.benson@curtin.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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