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

NCT06997926 | Active Not Recruiting

• 1 other identifier: N-20220025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Itch

Outcome Measures

Primary Outcomes (8)

• miRNA expression over time

  Plasma miRNA evaluation

  Before active/inactive cowhage

• miRNA expression over time

  Plasma miRNA evaluation

  30 minutes post-Active/inactive cowhage

• miRNA expression over time

  Plasma miRNA evaluation

  3 hours post-active/inactive cowhage

• miRNA expression over time

  Plasma miRNA evaluation

  24 hours post-active/inactive cowhage

• Protein expression over time

  Plasma protein evaluation

  Before active/inactive cowhage

• Protein expression over time

  Plasma protein evaluation

  30 minutes post-active/inactive cowhage

• Protein expression over time

  Plasma protein evaluation

  3 hours post-active/inactive cowhage

• Protein expression over time

  Plasma protein evaluation

  24 hours post-active/inactive cowhage

Secondary Outcomes (2)

• Assessment of itch: visual analog scale (VAS)

  Immediately after Active/inactive cowhage

• Assessment of pain: visual analog scale (VAS)

  Immediately after Active/inactive cowhage

Study Arms (2)

Active cowhage

ACTIVE COMPARATOR

The participant will receive active cowhage in the forearm.

Procedure: blood sampling

Inactive cowhage

SHAM COMPARATOR

The participant will receive inactive cowhage in the forearm.

Procedure: blood sampling

Interventions

blood sampling PROCEDURE

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

Active cowhage; Inactive cowhage

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women
• years
• Speak and understand English

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Gistrup, 9260, Denmark

Location

MeSH Terms

Conditions

Pruritus

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants are blinded about receiving active or inactive cowhage
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Two groups of subjects: one group will receive active cowhage spicules (itch inducer) and the other group will receive inactivated cowhage spicules (control)

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)