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

NCT02787356 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-10-09

No results posted yet for this study

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

Conditions

  • Skin Manifestations

Interventions

DRUG

TDS Lidocaine 5%; generic

TDS Lidocaine 5%; generic

DRUG

TDS Lidocaine 5%; RLD

TDS Lidocaine 5%; RLD

Sponsors & Collaborators

  • TKL Research, Inc.

    collaborator INDUSTRY

  • SRI International

    lead INDUSTRY

Principal Investigators

  • Jonathan Dosik, MD · TKL Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2017-12-31
Completion
2017-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02787356 on ClinicalTrials.gov