Characterization of the Toll-like Receptor 7-agonist Imiquimod 3.75% As a New Surrogate Model of … (NCT03943407) | Clinical Trial Compass
WithdrawnNot Applicable
Characterization of the Toll-like Receptor 7-agonist Imiquimod 3.75% As a New Surrogate Model of Itch
Stopped: The Imiquimod 3.75% was ineffective
Denmark0Started 2019-11-01
Plain-language summary
The aim of this research project is to design a new model of human itch by application of Zyclara cream. Further, the aim is to characterize the model and to verify if the mechanism of action of imiquimod follows the histaminergic or non-histaminergic pathway by using the anti-histamine drug doxepin. The last goal is to evaluate the interaction between the activation of TLR7 receptor and the activation of TRPA1 and TRPM8 receptors, which are two of the most important receptors involved in the transduction of noxious stimuli, and to evaluate to which extent these three channel populations functionally overlap.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy men and women
* 18-60 years
* Speak and understand English
Exclusion Criteria:
* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other drugs
* Previous or current neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate
* Current use of medications that may affect the trial
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Superficial blood perfusion by by a Speckle contrast imager (FLPI, Moor Instruments, England).
Timeframe: Change from baseline, to maximum 19 days after intervention
2
Trans-epidermal Water Loss (TEWL)
Timeframe: Change from baseline, to maximum 19 days after intervention
3
Neurogenic Inflammatory Response and Pigmentation
Timeframe: Change from baseline, to maximum 19 days after intervention
4
Measuring Alloknesis
Timeframe: Change from baseline, to maximum 19 days after intervention
5
Thermal measurements (cold and warm detection thresholds, cold and heat pain thresholds)
Timeframe: Change from baseline, to maximum 19 days after intervention
6
Measurement of Pain to Supra-threshold Heat Stimuli
Timeframe: Change from baseline, to maximum 19 days after intervention
7
Measurement of Mechanical Detection Thresholds, Mechanical Pain Threshold and sensitivity