Condition category
Not Applicable
Date applied
25/09/2018
Date assigned
08/10/2018
Last edited
08/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Allyl Isothiocyanate (AITC) is a compound found in common foods such as mustard and horseradish. It can be dissolved in oil and applied to the skin to activate sensory nerves to produce visible, measurable reactions (such as mild irritation or redness). These reactions are due in part to an increase in blood flow to the areas of AITC application on the skin. The increase in blood flow can be measured using a method called laser speckle contrast imaging. This study aims to develop a method to reliably measure the reactions caused by AITC applied to the skin using laser speckle contrast imaging. If successful, this method can be used in future clinical trials to test the ability of new drugs to reduce these reactions.

Who can participate?
Healthy volunteers of any gender aged 18-65

What does the study involve?
All participants have small volumes of AITC dissolved in mineral oil applied to their forearms during two visits, with a 2-week break between visits. The resulting reactions are examined using laser speckle contrast imaging about 1 week after each visit.

What are the possible benefits and risks of participating?
There is no clinical benefit to this trial. Possible side effects are easily treated and include mild skin redness, blistering, pain, or itching. Pain and itching are not expected to last longer than a few hours, but redness and blistering may take several weeks to subside.

Where is the study run from?
Quotient Clinical, Ltd (UK)

When is the study starting and how long is it expected to run for?
September 2017 to November 2018

Who is funding the study?
Genentech, Inc. (USA)

Who is the main contact?
global-roche-genentech-trials@gene.com, reference study ID GE40309

Trial website

Contact information

Type

Public

Primary contact

Dr Clinical Trials

ORCID ID

Contact details

1 DNA Way
South San Francisco
94080
United States of America

Additional identifiers

EudraCT number

2017-003498-33

ClinicalTrials.gov number

Protocol/serial number

GE40309

Study information

Scientific 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

Acronym

Study hypothesis

This study aims to demonstrate the safety and reproducibility of a topical challenge method to be used in Phase I clinical trials.

Ethics approval

Health and Social Care Research Ethics Committee A, 03/10/2017, Board Number: 17/NI/0183

Study design

Interventional single-center open-label single-group assignment

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contacts details to request a participant information sheet.

Condition

Topical application of allyl isothiocyanate

Intervention

Allyl Isothiocyanate (AITC) diluted in mineral oil: Participants will receive a small volume of 10% and 15% AITC (25 microliters), to be applied to localized forearm regions defined by small O-rings placed on the skin. AITC will be applied during two visits, with an approximately 2-week washout period between visits. Follow-up will occur approximately 1 week after each visit.The resulting reactions will be examined using laser speckle contrast imaging.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Reproducibility across two visits in the change in dermal blood flow after AITC challenge, measured by Laser Speckle Contrast Imaging at visits 1 and 2

Secondary outcome measures

1. Percentage of participants with adverse events (AEs), measured from baseline through to the end of the study (up to 24 days)
2. Pain and itch score, measured by interviewer-administered questionnaire at baseline and visits 1 and 2

Overall trial start date

01/09/2017

Overall trial end date

30/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

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
11. Presence of active allergy requiring treatment, as judged by the investigator
12. Presence or history of clinically significant skin disorders, as judged by the investigator
13. History of trauma or surgery to the arm but not including wrist or hand injury/surgery
14. Excessive forearm hair growth, tattoos or other physical or behavioural characteristics that may interfere with the study, as judged by the investigator
15. Participants who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 grams [g] per day paracetamol, hormone replacement therapy and hormonal contraception) in the 7 days before non-investigational medicinal product (AITC) administration
16. Failure to satisfy the investigator of fitness to participate for any other reason

Recruitment start date

20/10/2017

Recruitment end date

22/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Quotient Clinical Ltd, Clinical Research Unit
Mere Way
Nottingham
NG11 6JS
United Kingdom

Sponsor information

Organisation

Genentech, Inc

Sponsor details

1 DNA Way
South San Francisco
94080
United States of America

Sponsor type

Industry

Website

www.roche.com/about_roche/roche_worldwide.htm

Funders

Funder type

Industry

Funder name

Genentech

Alternative name(s)

Genentech, Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

United States of America

Results and Publications

Publication and dissemination plan

Publication is planned in a peer-reviewed journal. There is no current plan to make additional study documents available.

IPD sharing statement
Participant-level data will not be available because it is confidential, proprietary information. Study data will be held at Genentech, Inc.

Intention to publish date

20/11/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes