NCT04247230

Study to Determine the Effect of a Newly Formulated Tetracaine Product PET500 on Penile Skin Sensation

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Futura Medical Developments Ltd. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Tetracaine	Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
OTHER	Matching placebo (PET500)	Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
DRUG	STUD100	Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.

Timeline

• Start date: 2008-09-03
• Primary completion: 2008-10-20
• Completion: 2009-02-23
• First posted: 2020-01-30
• Last updated: 2020-01-30