drugset / Trial / NCT03096444

Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine

NCT03096444

Phase 2 Terminated 13 enrolled Gil Yosipovitch
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to examine the antipruritic efficacy of topical ketamine, amitriptyline, lidocaine, and a tri-combination of ketamine, amitriptyline and lidocaine (hereafter referred to as "KeAmLi") using non-histaminergic itch provocations in healthy volunteers. The primary outcome is itch reduction (AUC) between the vehicle and active treatment (KeAmLi-combo). Secondary outcomes include modality-specific analgesic properties of the topically applied ketamine, amitriptyline, lidocaine, and KeAmLi-combo to controlled quantitative thermal and mechanical stimuli, which can improve our understanding of the mechanism of action of these substances in the context of topical therapy.

Timeline

Start
2017-05-23
Primary completion
2017-07-19
Completion
2017-07-21

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Amitriptyline Small molecule 5 % Topical
Subject Amitriptyline Small molecule 2 g Topical
Subject Ketamine Small molecule 10 % Topical
Subject Ketamine Small molecule 2 g Topical
Subject Lidocaine Other / unclassified 5 % Topical
Subject Lidocaine Other / unclassified 2 g Topical

Indications

No indication recorded.