Exploratory skin challenge study using laser speckle contrast imaging to develop and assess the reproducibility of a method for assessing changes in forearm skin blood flow in healthy human volunteers before and after topical application of allyl isothiocyanate

Genentech, Inc0 sites23 target enrollmentOctober 8, 2018

Overview

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32415670/ (added 07/01/2022)

Registry

who.int

Start Date

October 8, 2018

End Date

November 30, 2018

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Participants must be willing and able to communicate and participate in the whole study
•2\. Able to sit or lay down for up to 2 hours

•1\. Participants who have received any investigational medicinal product (IMP) in a clinical research study within at least 3 months of the first date of skin challenge (Visit 1\)
•2\. Participants who are study site employees, or immediate family members of a study site or sponsor employee
•3\. Participants who have previously been enrolled in this study
•4\. History of any drug or alcohol abuse in the past 2 years
•5\. Regular alcohol consumption in males greater than (\>) 21 units per week and females \>14 units per week
•6\. Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 parts per million (ppm)
•7\. Positive drugs of abuse test result
•8\. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder, as judged by the investigator
•9\. History of serious adverse reaction or serious hypersensitivity to the challenge agent (AITC), vehicle (mineral oil), or procedures
•10\. History of dermatographism