Local Anaesthetic Effects of Transcutaneous Amitriptyline
University Hospital, Clermont-Ferrand
The aim of this study is to assess the local anaesthetic effects of amitriptyline applied on
the skin of human volunteers, considering the differential effects on mechanic and thermic
sensitivity, the local and general tolerance, and the systemic absorption of the drug. The
solution used for dilution of amitriptyline is the only one known to allow transcutaneous
absorption of the drug . Considering that the peripheral sensitive fibre is a possible
site of action of tricyclic antidepressants for relieving neuropathic pain [2,3], this is a
first step study before further assessment of the therapeutic effects of transcutaneous
Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation
Phase 2/Phase 3
The purpose of this study is to evaluate the effectiveness, safety and tolerability of the
investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug,
PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic
(numbing) spray containing a mixture of lidocaine and prilocaine. The study drug will be
applied in a spray to the penis prior to intercourse in order to decrease sensitivity in an
attempt to delay ejaculation.
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