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Completed

NCT Number: NCT04588532

Characterization of BAM8-22 as a New Surrogate Model of Non-histaminergic Itch

With this experiment, the experimenter wish to asses if substance BAM8-22 (Bovine Adrenal Medulla) induce non-histaminergic itch.

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Key information

Conditions

Itch Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University

Aalborg, 9000, Denmark

About this study

With this experiment, the experimenter wish to establish if the substance BAM8-22 (Bovine Adrenal Medulla) induce a non-histaminergic itch by using the antihistamine Doxepin.

The experimenter will also compare itch and the response to antihistamine of BAM8-22, histamine and cowhage.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 drugs
  • Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.)
  • Moles, wounds, scars or tattoos in the area to be treated or tested
  • Lack of ability to cooperate •
  • Current use of medications that may affect the trial such as antihistamines and pain killers.
  • Skin diseases
  • Consumption of alcohol or painkillers 24 hours before the study days and between these - Acute or chronic pain •
  • Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)

Treatment and study plan

BAM8-22

Drug

Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

Histamine

Drug

histamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

Cowhage (Mucuna Pruriens)

Drug

cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)

Doxepin

Drug

Doxepin cream (antihistamine) will be applied in 4 areas on the volar forearm

Primary outcomes

  1. superficial blood perfusion

    Time frame: change from baseline, up to 10 minutes after the first session

    is measured by a speckle contrast imager (FLPI, Moor Instruments, England)

  2. Warm Detection Threshold, and Heat Pain threshold

    Time frame: change from baseline, up to 10 minutes after the first session

    the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  3. Cold Detection Threshold and Cold Pain threshold

    Time frame: change from baseline, up to 10 minutes after the first session

    the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  4. Pain supra-threshold heat Stimuli

    Time frame: change from baseline, up to 10 minutes after the first session

    the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  5. hyperknesis (abnormal pruriceptive state)

    Time frame: change from baseline, up to 10 minutes after the first session

    is measured by using a mildly pruritic, non-painful von Frey filaments of a predetermined intensity (generally 5-30 milliNewton of force)

  6. mechanical pain threshold and sensitivity

    Time frame: change from baseline, up to 10 minutes after the first session

    is performed using a pin-prick set (Aalborg University). The set consists of 8 needles each having a diameter of 0,6 mm and different force applications

  7. itch rating

    Time frame: change from baseline, up to 10 minutes after the first session

    the subject will rate the itch for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates "no itch" and 100 indicates "worst imaginable itch"

Secondary outcomes

  1. pain rating

    Time frame: change from baseline, up to 10 minutes after the first session

    the subject will rate the pain for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates "no pain" and 100 indicates "worst imaginable pain"

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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