Laser Speckle Contrast Imaging Skin Challenge Study (QCL118186)
Research type
Research Study
Full title
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
IRAS ID
213825
Contact name
Eric Olson
Contact email
Sponsor organisation
Genentech, Inc.
Duration of Study in the UK
0 years, 1 months, 20 days
Research summary
The sponsor is investigating new potential therapies for asthma that work by targeting receptors found in the airways and skin. In order to determine whether the new therapies are effective, the sponsor is developing a method of measuring the change in blood flow that may occur after the new therapy is given. Therefore the purpose of this study is to develop a method for measuring the change in blood flow that may be used in future trials to see how a test medicine affects the body.
AITC is a naturally occurring substance that has been shown to cause irritation and itch when put in contact with the skin and coughing. AITC is found in mustard, radishes, horseradish and wasabi. AITC causes itching, irritation and coughing by activating certain receptors in the skin and airways. The test medicine being developed in this study will target and block these receptors to hopefully prevent the itching and coughing.
The study will consist of up to 2 visits, involving up to 30 healthy male and female subjects (at least 10 of each gender). During visit 1, all of the subjects will receive topical applications of 2 different concentrations of AITC on 2 separate locations of their forearms. The blood flow in the designated application areas will be measured before and after the application of the AITC using Laser Speckle Contrast Imaging (PeriMed). Subjects who have more than a 100% increase in blood flow after the application of the highest concetration of AITC will come in to repeat the test during the second visit to test the reproducibility of results. If the volunteer does not respond to the AITC at the first visit, they will be discontinued from the study.
REC name
HSC REC A
REC reference
17/NI/0183
Date of REC Opinion
3 Oct 2017
REC opinion
Favourable Opinion