ItchNCT06997926
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
A study testing blood sampling in people with Itch, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Itch
- What is being tested?
- blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- 18-60 years
- Speak and understand English
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of the Mechanism of Non-histaminergic Itch Probing Epigenetic Changes Following Cowhage Application
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.
Read the detailed description
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.
- Conditions
- Itch
- Being tested
- blood sampling
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingProcedure or surgery
Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected
| Study group | Role | What they receive |
|---|---|---|
| Active cowhage | Active comparator | The participant will receive active cowhage in the forearm. Receives: Procedure: blood sampling |
| Inactive cowhage | Sham comparator | The participant will receive inactive cowhage in the forearm. Receives: Procedure: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA expression over time
Plasma miRNA evaluation
Measured: Before active/inactive cowhage
miRNA expression over time
Plasma miRNA evaluation
Measured: 30 minutes post-Active/inactive cowhage
miRNA expression over time
Plasma miRNA evaluation
Measured: 3 hours post-active/inactive cowhage
miRNA expression over time
Plasma miRNA evaluation
Measured: 24 hours post-active/inactive cowhage
Protein expression over time
Plasma protein evaluation
Measured: Before active/inactive cowhage
Protein expression over time
Plasma protein evaluation
Measured: 30 minutes post-active/inactive cowhage
Protein expression over time
Plasma protein evaluation
Measured: 3 hours post-active/inactive cowhage
Protein expression over time
Plasma protein evaluation
Measured: 24 hours post-active/inactive cowhage
Secondary outcomes (2)
Assessment of itch: visual analog scale (VAS)
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).
Measured: Immediately after Active/inactive cowhage
Assessment of pain: visual analog scale (VAS)
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).
Measured: Immediately after Active/inactive cowhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start15 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ItchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of subjects: one group will receive active cowhage spicules (itch inducer) and the other group will receive inactivated cowhage spicules (control)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Lo Vecchio, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997926
- Sponsor's protocol ID
- N-20220025
- Status last verified
- Nov 2026
- First submitted
- 22 May 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Mechanism of Non-histaminergic Itch Probing Epigenetic Changes Following Cowhage Application
- ClinicalTrials.gov ID
- NCT06997926
- Acronym / sponsor ID
- N-20220025
- Conditions
- Itch
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups of subjects: one group will receive active cowhage spicules (itch inducer) and the other group will receive inactivated cowhage spicules (control)
| Arm | Type | Receives |
|---|---|---|
| Active cowhage | Active comparator | Procedure: blood samplingThe participant will receive active cowhage in the forearm. |
| Inactive cowhage | Sham comparator | Procedure: blood samplingThe participant will receive inactive cowhage in the forearm. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women
- 18-60 years
- Speak and understand English
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingWhole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected | Procedure or surgery | Active cowhage, Inactive cowhage |
Primary outcome
miRNA expression over time
Time frame: Before active/inactive cowhage
Plasma miRNA evaluation
miRNA expression over time
Time frame: 30 minutes post-Active/inactive cowhage
Plasma miRNA evaluation
miRNA expression over time
Time frame: 3 hours post-active/inactive cowhage
Plasma miRNA evaluation
miRNA expression over time
Time frame: 24 hours post-active/inactive cowhage
Plasma miRNA evaluation
Protein expression over time
Time frame: Before active/inactive cowhage
Plasma protein evaluation
Protein expression over time
Time frame: 30 minutes post-active/inactive cowhage
Plasma protein evaluation
Protein expression over time
Time frame: 3 hours post-active/inactive cowhage
Plasma protein evaluation
Protein expression over time
Time frame: 24 hours post-active/inactive cowhage
Plasma protein evaluation
2 secondary outcomes
Assessment of itch: visual analog scale (VAS)
Time frame: Immediately after Active/inactive cowhage
Assessment of pain: visual analog scale (VAS)
Time frame: Immediately after Active/inactive cowhage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Itch, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNA expression over time (time frame: Before active/inactive cowhage). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.