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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06328530
Other study ID # N-20210046 3rd project
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date December 31, 2026

Study information

Verified date May 2024
Source Aalborg University
Contact Silvia Lo Vecchio, PhD
Phone +4521397785
Email slv@hst.aau.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In This experiment, the investigators would like to design a new itch model based on the spatial summation of pruritic stimuli. The hypothesis behind this study (spatial summation) is that two simultaneous applications of pruritogens will result in higher itch sensation compared with a single application of pruritogen.


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 the spatial summation of pruritic stimuli. The aim of this experiment is to assess the itch sensation induced by simultaneous application of pruritogens (spatial summation). In particular, the purpose is to evaluate if a single application of cowhage/histamine (non-histaminergic and histaminergic itch respectively) results in a lower itch sensation compared to two simultaneous applications of the pruritogens, on the same arm or in different arms.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
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 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cowhage
25 spicules will be inserted in the center of the predefined skin area on the mandibular area. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration.
Histamine
Histaminergic itch will be evoked by a 1% histamine solution. A droplet of histamine solution will be placed on the predetermined area on the forearm, and the SPT lancet will be pierced through the histamine with 120 g of pressure for 1-2 seconds.

Locations

Country Name City State
Denmark Aalborg University Aalborg

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

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 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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