drugset / Trial / NCT02787356
Standard TDS Irritation Study: Trained Skin Grader vs. Digital Imaging
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lidocaine | Other / unclassified | 5 % | Other |