drugset / Trial / NCT02787356

Standard TDS Irritation Study: Trained Skin Grader vs. Digital Imaging

NCT02787356 ↗

RandomizedParallel-groupDouble-blindOther

Summary

The purpose of this study is to (1) collect trained observer scores and digital images of skin irritated by generic and RLD Lidocaine 5% delivered via TDS, and (2) assess performance of an automated system for predicting scores directly from the digital images

Timeline

Start
2017-10-01
Primary completion
2017-12
Completion
2017-12

Outcome

Outcome not reported

Stopped (Business): “Project was not funded by FDA”

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 5 % Other

Indications