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NCT Number: NCT06997926

Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes

Itch is defined as an unpleasant sensation that evokes the desire to scratch. Chronic itch, defined as itch persisting for more that 6 weeks, is a key symptom in many diseases severely affects the quality of life of the affected patients and represents a substantial economic burden for the society. At present, there are no effective treatments for chronic itch diseases. Moreover, chronic itch patients express differences in their genes compared with people who do not suffer from itch.

With this experiment, we wish to analyse differences in genes expression in healthy volunteers who have been exposed to artificial itch from small plant needles from the plant cowhage (mucuna pruriens) and compare them to controls who have not been exposed to itch.

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This study is active but is not currently recruiting participants.

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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, 9260, Denmark

About this study

The study takes place over 2 sessions over a period of 2 days. Thirty healthy participants will be randomly allocated into two groups named "active group", treated with active cowhage spicules, and "control group", exposed to inactivated cowhage spicules.

During the 1st session, the participant will fill out a questionnaire including basic information and after participants in the active group will be treated with cowhage spicules for 15 minutes, while participants in the control group will receive the inactivated cowhage spicules. All subjects will be provided with a visual analog scale in which they have to report continuously the sensation of itch and pain on a scale from 0 to 100 for 15 minutes. Before cowhage application, 30 minutes and 3 hours after cowhage application, blood samples will be collected from all participants. The 2nd session will take place 24 h after the 1st session and in this session the final blood sample will be collected.

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 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
  • Allergy to lidocaine
  • 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
  • Smoking
  • Acute or chronic pain
  • Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)

Treatment and study plan

blood sampling

Procedure

Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected

Primary outcomes

  1. miRNA expression over time

    Time frame: Before active/inactive cowhage

    Plasma miRNA evaluation

  2. miRNA expression over time

    Time frame: 30 minutes post-Active/inactive cowhage

    Plasma miRNA evaluation

  3. miRNA expression over time

    Time frame: 3 hours post-active/inactive cowhage

    Plasma miRNA evaluation

  4. miRNA expression over time

    Time frame: 24 hours post-active/inactive cowhage

    Plasma miRNA evaluation

  5. Protein expression over time

    Time frame: Before active/inactive cowhage

    Plasma protein evaluation

  6. Protein expression over time

    Time frame: 30 minutes post-active/inactive cowhage

    Plasma protein evaluation

  7. Protein expression over time

    Time frame: 3 hours post-active/inactive cowhage

    Plasma protein evaluation

  8. Protein expression over time

    Time frame: 24 hours post-active/inactive cowhage

    Plasma protein evaluation

Secondary outcomes

  1. Assessment of itch: visual analog scale (VAS)

    Time frame: Immediately after Active/inactive cowhage

    Itch following pruritogens will be monitored for 15 minutes using a computerized 100 mm visual analog scale (eVAS software Aalborg University, Denmark), installed on a tablet. The scale range from 0 (no itch) to 100 (worst imaginable itch).

  2. Assessment of pain: visual analog scale (VAS)

    Time frame: Immediately after Active/inactive cowhage

    Pain following pruritogen will be monitored for 15 minutes using a computerized 100 mm visual analog scale (eVAS software Aalborg University, Denmark), installed on a tablet. The scale range from 0 (no pain) to 100 (worst imaginable pain).

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

Identification of the Mechanism of Non-histaminergic Itch Probing Epigenetic Changes Following Cowhage Application

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 31, 2025
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.

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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