A study to validate a method of measurement of dermal blood flow in healthy human volunteers after topical application of allyl isothiocyanate (AITC)
- Conditions
- Topical application of allyl isothiocyanateNot Applicable
- Registration Number
- ISRCTN97082664
- Lead Sponsor
- Genentech, Inc
- Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32415670/ (added 07/01/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 23
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method <br> 1. Percentage of participants with adverse events (AEs), measured from baseline through to the end of the study (up to 24 days)<br> 2. Pain and itch score, measured by interviewer-administered questionnaire at baseline and visits 1 and 2<br>