The assessment of local response to topical menthol gel and capsaicin gel applied with and without microneedle pretreatment
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
Curtin University
60 participants
Mar 25, 2013
Interventional
Conditions
Summary
The study is investigating the sensations that people feel when different menthol or capsaicin gel is placed on their skin over a 15-minute time frame and whether the onset of these sensations occurs more quickly when the skin is pretreated with microneedles (tiny needles that push a very short distance into the skin). We hypothesise that the microneedles will increase permeation of the applied drugs across the skin giving faster and more intense sensations.
Eligibility
Inclusion Criteria1
- healthy skin, without any underlying comorbidities, or known allergies to menthol or capsaicin.
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Interventions
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.
Locations(1)
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ACTRN12613000319774