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Repetitive Applications of Pruritogens and Effects of a Cutaneous-induced Pain Stimulation on Nonhistaminergic Itch Perception

Repetitive Applications of Pruritogens and Effects of a Cutaneous-induced Pain Stimulation on Nonhistaminergic Itch Perception

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06154824
Enrollment
30
Registered
2023-12-04
Start date
2023-12-15
Completion date
2025-05-30
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cowhage, Histamine

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.

Interventions

OTHERHistamine

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

OTHERCowhage

25 spicules will be inserted in the centre 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

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Participant will be blinded about application of pruritogens.

Intervention model description

The participants will randomly receive 3 consecutive applications of cowhage and histamine.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Assessment of itch intensity1 minute post itch provocationImmediately 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'.
Assessment of pain intensity1 minute post itch provocationImmediately 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'.

Secondary

MeasureTime frameDescription
Superficial blood perfusion10 minutes post itch provocationThe evoked cutaneous inflammation (quantified by superficial blood perfusion) will be measured by full-field laser perfusion imaging.
Alloknesis12 minutes post itch provocationAlloknesis sensation is measured using a standardized sensory brush (SENSELab Brush-05, Somedic AB, Hörby, Sweden) exerting a force of 200 to 400 mN.
Mechanically evoked itch15 minutes post itch provocationMechanically 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).

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026