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NCT Number: NCT06503510

Role of Interleukin-13 Pathways on Pain and Itch Sensitivity

Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the proteins interleukins are involved in inflammation and itch in atopic dermatitis. The medicinal product called Lebrikizumab, used for treatment of AD, has shown to block the interleukin called IL-13. The purpose of this experiment is to evaluate the role of IL-13 in itch in both healthy subjects and people with atopic dermatitis.

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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, Gistrup, Aalborg, Denmark

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About this study

Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the interleukin-13 is involved in inflammation and itch in atopic dermatitis by increasing the neuronal sensitivity to pruritogens. However, the physiological mechanisms by which IL-13 increases the itch sensitivity are unclear. The aim of this project is to use, for the first time in humans, the monoclonal antibody Lebrikizumab that inhibits IL-13 with high affinity as a novel experimental tool to modulate the IL-13 pathway and evaluate its role in the transmission and processing of itch and pain.

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

Exclusion criteria

  • Pregnancy or lactation
  • Drug addiction defined as any use of cannabis, opioids, or other drugs
  • Previous or current history of neurological, dermatological (e.g., AD, psoriasis, etc.), immunological, musculoskeletal, cardiac disorder, or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.)
  • Moles, wounds, scars, or tattoos in the area to be treated or tested
  • Current use of medications that may affect the trial such as antihistamines and pain killers (use of antihistamines should be discontinued 72 hours before the experiment and all topical agents and emollients should be discontinued 24 hours before the experiment).
  • Use of systemic and topical corticosteroids
  • 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)
  • Lack of ability to cooperate

Treatment and study plan

Histamine

Other

A small drop of histamine dihydrochloride (1%, in saline) will be applied to a previously determined area on the volar forearm followed by a prick through the drop.

Cowhage

Other

Approximately 30-35 cowhage spicules will be manually inserted into the subject's skin.

bovine adrenal medulla (BAM8-22)

Other

A small drop of BAM8-22 solution will be applied to a previously determined area on the volar forearm followed by a prick through the drop.

Primary outcomes

  1. Measuring itch by computerized Visual Analog Scale Scoring

    Time frame: 1 minute after every itch induction

    The subjects will be asked to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable".

  2. Measuring pain by computerized Visual Analog Scale Scoring

    Time frame: 1 minute after every itch induction

    The subjects will be asked to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".

  3. Superficial blood perfusion

    Time frame: Baseline

    Superficial blood perfusion (SBP) is measured by a Speckle contrast imager

  4. Superficial blood perfusion

    Time frame: 10 minute after every itch induction

    Superficial blood perfusion (SBP) is measured by a Speckle contrast imager

  5. Wheal reaction

    Time frame: 10 minute after every itch induction

    Wheal reaction measurement will be conducted immediately after the removal of pruritogens by measuring the longest diameter with a ruler.

  6. Average pruritis and pain numerical rating scale (NRS)

    Time frame: Baseline

    The subject will be asked to retrospectively rate the average and worst itch/pain on an 11-point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)experience they had during the last 7 days.

  7. Skin peak pain numerical rating scale (SPP-NRS)

    Time frame: Baseline

    According to the SPP-NRS, the subject will be asked about "worst skin pain" they felt in the past 24 hours on an 11-point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  8. Peak pruritus numerical rating scale (PP-NRS)

    Time frame: Baseline

    The subject will be asked about the "worst itch" they felt in the past 24 hours on an 11-point scale ranging from 0 to 10 (0 = no itch and 10 = worst imaginable itch)

  9. Mechanically evoked itch (MEI)

    Time frame: Baseline

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

  10. Mechanically evoked itch (MEI)

    Time frame: 10 minutes after every itch induction

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

Secondary outcomes

  1. Mechanical Pain Thresholds (MPT)

    Time frame: Baseline

    This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN.

  2. Mechanical Pain Sensitivity (MPS)

    Time frame: Baseline

    This test is conducted with the same pinprick set used to test the MPT.

  3. Pressure Pain Thresholds (PPT)

    Time frame: Baseline

    Pressure will be applied by a handheld electronic pressure algometer (Somedic AB, Stockholm, Sweden) on to the supinator muscle on the left forearm.

  4. Cold Detection Thresholds (CDT)

    Time frame: Baseliene

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

  5. Warm Detection Thresholds (WDT)

    Time frame: Baseline

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testingdevice

  6. Cold Pain Thresholds (CPT)

    Time frame: Baseline

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

  7. Heat Pain Thresholds (HPT)

    Time frame: Baseline

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

  8. Pain to Supra-threshold Heat Stimuli (STHS)

    Time frame: Baseline

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

Study contacts

Contact information is provided by the study sponsor or research team.

Silvia Lo Vecchio

CONTACT

[email protected]

21397785

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

The Role of the Interleukin-13 Pathways on Pain and Itch Sensitivity in Patients With Atopic Dermatitis and Healthy Volunteers

Acronym: IL-13

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 16, 2024
Registry last updated
Jun 4, 2025

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

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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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