Topical application of allyl isothiocyanate Not Applicable
Conditions
Interventions
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 p
Sponsors
Genentech, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactClinical Trials
Outcome results
None listed