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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
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06185582
Enrollment
30
Registered
2023-12-29
Start date
2023-12-15
Completion date
2025-06-30
Last updated
2023-12-29

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

Conditions

Capsaicin, Pain, Burning

Brief summary

In This experiment, the investigators would like to test following hypotheses: the pain stimulation applied at the same time of a pruriceptive stimulus will decrease the itch perception. Moreover, also the effect of the cutaneous pain stimulus location (same forearm of the pruriceptive stimulus versus the opposite forearm) on histaminergic and non-histaminergic itch will be investigated.

Detailed description

The phenomenon that pain inhibits pain is a well-known mechanism, but it is not known if pain is inhibiting itch. In this context, the aim of this project is to investigate the extent to which thermal or neurogenic short cutaneous pain can affect the itch perception. In particular, the project aims to understand any differences in itch perception when the painful stimulation is applied on the same forearm versus the opposite forearm. The hypothesis is that by applying a painful stimulus at the same time of an itchy stimulus, the itch sensitivity will decrease; probably due to an inhibitory process conducted by interneurons (Bhlbb5 interneuron) at central level.

Interventions

OTHERCowhage

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.

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 sub-project takes place over three sessions on three consecutive days. The participants will randomly receive two pruritogens and two pain stimulations (heat or capsaicin) in the same and in the opposite arm.

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 intensity using a VAS scale1 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 intensity using a VAS scale1 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'.
Retrospective rating of the pain perceived on a NRS10 minutes post itch provocationAfter 10 minutes of pruritogens application, a retrospective rating of the pain perceived from the thermal pain/capsaicin will be provided by the subject using a numeral rating scale (NRS)

Secondary

MeasureTime frameDescription
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