An open label, placebo and positive controlled, randomised, cross-over study in healthy male volunteers to determine the effect on penile skin sensation of a newly formulated tetracaine product PET500
This was an open label, placebo and positive controlled, randomised, dose-ranging, cross-over pilot study. On each dosing day the subjects each received one dose of tetracaine (0.26 or 0.65 or 1.3mg), or placebo, or Stud100® (which served as a positive control) on the glans penis The doses of PET500 were applied in liquid spray form (260μl) at approximately the same time of the day as the previous application to locations on the glans penis in a randomised fashion. Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP. The first two volunteers included in the trial piloted the sensitivity assessments prior to the inclusion of all other subjects. Changes could be made to the assessment times on the basis of the pilot data to ensure subsequent timings were relevant. However any such changes were not to expose volunteers to more assessments than were specified in the study protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
Onset of action of different doses of a newly formulated tetracaine spray PET500 when applied to the glans penis assessed using Von Frey fibres (monofilaments) to measure touch sensitivity
To determine the onset of action of different doses of a newly formulated tetracaine spray PET500 when applied to the glans penis (compared to placebo and positive prilocaine/lidocaine control).
Time frame: 2 Months
Duration of action of different doses of a newly formulated tetracaine spray PET500 when applied to the glans penis using Von Frey fibres (monofilaments) to measure touch sensitivity
To determine the duration of action of different doses of a newly formulated tetracaine spray PET500 when applied to the glans penis (compared to placebo and positive prilocaine/lidocaine control).
Time frame: 2 Months
Incidence of adverse events for PET500
To determine incidence, of adverse events by Treatment group for doses of a newly formulated tetracaine spray PET500 in healthy male volunteers.
Time frame: 2 months
Intensity and relationship of adverse events to PET500
To determine intensity and relationship to study drug of adverse events by Treatment group for doses of a newly formulated tetracaine spray PET500 in healthy male volunteers.
Time frame: 2 months
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