Histamine Clinical Trial
Official title:
Repetitive Applications of Pruritogens and Effects of a Cutaneous-induced Pain Stimulation on Nonhistaminergic Itch Perception
In This experiment, the investigators would like to design a new itch model based on the temporal summation of pruritic stimuli. The hypothesis behind this study (temporal summation) is that two overlapped applications of pruritogens will result in a higher itch sensation compared with a single application.
Status | Not yet recruiting |
Enrollment | 26 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Healthy men and women - 18-60 years - Speak and understand Englis 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) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Aalborg University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of itch | Immediately following the itch provocations, participants will be instructed to rate the itch intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no itch' and 100 'worst itch imaginable'. | 1 minute after every itch inductions | |
Primary | Assessment of pain | Immediately following the itch provocations, participants will be instructed to rate the pain intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no pain' and 100 'worst pain imaginable' | 1 minute after every itch inductions | |
Secondary | Microvascular reactivity | The evoked cutaneous inflammation (quantified by superficial blood perfusion) will be measured by full-field laser perfusion imaging. | 10 minutes after every itch inductions | |
Secondary | Alloknesis | Alloknesis sensation is measured using a standardized sensory brush (SENSELab Brush-05, Somedic AB, Hörby, Sweden) exerting a force of 200 to 400 mN. | 12 minutes after every itch inductions | |
Secondary | Mechanically evoked itch | Mechanically evoked itch is measured using three von Frey filaments of 4.08, 4.16 and 4.31 (1.0, 1.4, 2.0 g, respectively) (North Coast Medical, Gilroy, CA). The center of the skin area is stimulated by 3 pricks, repeated 3 times in short succession. After a total of 9 stimulations, the participants will report the itch elicited on a numerical rating scale (NRS) from 0 to 10 (0 = "no itch"; 10 = "worst imaginable itch"). | 15 minutes after every itch inductions |
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