Clinical trial NCT06154824: Repetitive Applications of Pruritogens and Effects of a Cutaneous-induced Pain Stimulation on Nonhistaminergic Itch Perception
Official title: Repetitive Applications of Pruritogens and Effects of a Cutaneous-induced Pain Stimulation on Nonhistaminergic Itch Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Histamine
Cowhage
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The participants will randomly receive 3 consecutive applications of cowhage and histamine.
Primary purpose: BASIC_SCIENCE

Brief summary: In This experiment, the investigators would like to test following hypotheses:

repetitive cutaneous administration of pruritogens will lead to a more robust and longer lasting itch sensation compared with a single application. The aim of this project is to investigate a new itch model based on repetitive administration of three different pruritogens: histamine (histaminergic itch), cowhage, and BAM 8-22 (non-histaminergic itch).

Detailed description: Chronic itch affects approximately a fifth of the global population and is associated with substantial negative consequences for the affected individuals. Furthermore, there is a lack of efficient treatment options for chronic itch. In order to mimic a clinical itch condition as presented in patients, the aim of the project is to investigate a new itch model based on repetitive administration of three different pruritogens: histamine (histaminergic itch), cowhage, and BAM 8-22 (non-histaminergic itch). The hypothesis is that repetitive cutaneous administration of pruritogens will lead to a more robust and longer-lasting itch sensation compared with a single application. This proposal for a new itch model could better mimic clinical itch conditions and be used to investigate fundamental mechanisms, new anti-pruritic drugs, and their possible mechanisms of action.

Eligibility criteria: 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 addictive drugs
* Previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis) musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder, or mental illnesses that may affect the results
* Lack of ability to cooperate
* Current use of medications that may affect the trial such as antihistamines, antipsychotics, and pain killers, as well as systemic or topical steroids
* Skin diseases (e.g. atopic dermatitis, pruritus nodularis, eczema, psoriasis)
* Moles, scars, or tattoos in the area to be treated or tested.
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)

Primary outcomes:
measure: Assessment of itch intensity
timeFrame: 1 minute post itch provocation
measure: Assessment of pain intensity
timeFrame: 1 minute post itch provocation
Secondary outcomes:
measure: Superficial blood perfusion
timeFrame: 10 minutes post itch provocation
measure: Alloknesis
timeFrame: 12 minutes post itch provocation
measure: Mechanically evoked itch
timeFrame: 15 minutes post itch provocation
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
References: