ITCHNCT07247695
Mechanisms Underlying the Placebo Effect in Both Histaminergic and Non-histaminergic Itch
A study testing Histamine and Cowhage in people with ITCH, run by Aalborg University at 1 site in Denmark.
Trial summary
The study consists of one experimental session of approximately 1½ hours. The participant will fill in a series of questionnaires about how you perceive itch and pain, and about some traits of your personality, such as depression, anxiety and stress. 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?
- Histamine and Cowhage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Nov 2025to 31 Dec 2028
- 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 drugs
- Previous or current history of neurological, 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
- Skin diseases
Show all 11Show fewer
- Consumption of alcohol or painkillers 24 hours before the study days and between these
- Acute or chronic pain and itch
- Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical studies)
- Contraindications to capsaicin, including intolerance to chili or burns or wounds at the application site
- The subject is assessed as unable to engage in the necessary cooperation required by the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University
Gistrup, 9260
Silvia Lo Vecchio, PhD, Denmark, slv@hst.aau.dk
Denmark
About this study
Official title: Pain and Itch Neuromodulation: Effects of Offset Analgesia, Placebo, and Nocebo and Topographical Distribution of Itch and Pain Receptors
The study consists of one experimental session of approximately 1½ hours. The participant will fill in a series of questionnaires about how you perceive itch and pain, and about some traits of your personality, such as depression, anxiety and stress. Afterwards, two areas will be selected on each forearm of the subjects. The four areas will be treated with the same vehicle cream for 20 minutes, in order to test the placebo effect. At the end of the cream application, two areas will be randomly treated with histamine while cowhage will be applied on the other two areas. During the 10 minutes of the application of the pruritogens, itch and pain will be continuously monitored using a Visual Analog Scale.
- Conditions
- ITCH
- Being tested
- Histamine, Cowhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistamineOther
To deliver histamine, standard allergy skin prick test (SPT) lancets are applied
CowhageOther
The spicules will be manually inserted. Approximately 30-35 spicules are gently rubbed into a 1 cm diameter skin area on the forearm/face
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | A placebo cream (Pentravan cream) will be applied on the volar forearm for 20 minutes. Receives: Other: Histamine; Other: Cowhage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring pain by computerized Visual Analog Scale Scoring
We will ask the subjects to rate the sensation of pain on a 100 mm Visual Analog Scale ranging from 0 to 100 where 0 indicates" no pain" and 100 indicates "worst pain imaginable".
Measured: Immediately after the intervention
Measuring itch by computerized Visual Analog Scale Scoring
We will ask the subjects to rate the sensation of itch on a 100 mm Visual Analog Scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable".
Measured: Immediately after the intervention
Secondary outcomes (8)
Pain Catastrophizing Scale (PCS).
The PCS assesses negative and exaggerated coping concerning anticipated or experienced painful stimuli. Thirteen items have to be answered on a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (all the time).
Measured: Baseline
Itch Catastrophizing Scale (ICS).
The ICS assesses negative and exaggerated coping concerning anticipated or experienced itchy stimuli. Thirteen items have to be answered on a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (all the time).
Measured: Baseline
Learned Helplessness Scale (LHS)
The questionnaire consists of 20 items, and the participant's response to each item is rated on a 4-point Likert scale ranging from strongly agree (1) to strongly disagree (4).
Measured: Baseline
Depression, Anxiety, Stress Scale (DASS-21)
The questionnaire measures the magnitude of depression, anxiety, and stress. Each of these three subscales consists of 7 questions answered using a 0-3 Likert scale, with 0 meaning "it did not apply to me", and 3 meaning "it applied to me very much"
Measured: Baseline
Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).
The RST-PQ contains in total 65 items must be answered on a Response scale: 4-point Likert (Strongly disagree → Strongly agree).
Measured: Baseline
Positive And Negative Affect Schedule (PANAS)
Twenty words are associated with the subject's current feelings and have to be rated on a 5-points Likert-type scale from: Very slightly or not at all to extremely.
Measured: Baseline
Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
The questionnaire is an 18-item measure used to identify emotional regulation issues in adults. Participants rate each item on a 5-point Likert scale (from 1 to 5).
Measured: Baseline
Emotion Regulation Questionnaire (ERQ
This questionnaire is designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree), where 4 means (neutral).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start3 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- Investigators
- Silvia Lo Vecchio, Principal investigator, Aalborg Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247695
- Sponsor's protocol ID
- N-20250017 Project 2
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Itch Neuromodulation: Effects of Offset Analgesia, Placebo, and Nocebo and Topographical Distribution of Itch and Pain Receptors
- ClinicalTrials.gov ID
- NCT07247695
- Acronym / sponsor ID
- N-20250017 Project 2
- Conditions
- ITCH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Nov 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.
The study consists of one experimental session of approximately 1½ hours. The participant will fill in a series of questionnaires about how you perceive itch and pain, and about some traits of your personality, such as depression, anxiety and stress. Afterwards, two areas will be selected on each forearm of the subjects. The four areas will be treated with the same vehicle cream for 20 minutes, in order to test the placebo effect. At the end of the cream application, two areas will be randomly treated with histamine while cowhage will be applied on the other two areas. During the 10 minutes of the application of the pruritogens, itch and pain will be continuously monitored using a Visual Analog Scale.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Other: Histamine, Other: CowhageA placebo cream (Pentravan cream) will be applied on the volar forearm for 20 minutes. |
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 (11 listed)
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids, or other drugs
- Previous or current history of neurological, 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
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 |
|---|---|---|
| HistamineTo deliver histamine, standard allergy skin prick test (SPT) lancets are applied | Other | Placebo |
| CowhageThe spicules will be manually inserted. Approximately 30-35 spicules are gently rubbed into a 1 cm diameter skin area on the forearm/face | Other | Placebo |
Primary outcome
Measuring pain by computerized Visual Analog Scale Scoring
Time frame: Immediately after the intervention
We will ask the subjects to rate the sensation of pain on a 100 mm Visual Analog Scale ranging from 0 to 100 where 0 indicates" no pain" and 100 indicates "worst pain imaginable".
Measuring itch by computerized Visual Analog Scale Scoring
Time frame: Immediately after the intervention
We will ask the subjects to rate the sensation of itch on a 100 mm Visual Analog Scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable".
8 secondary outcomes
Pain Catastrophizing Scale (PCS).
Time frame: Baseline
Itch Catastrophizing Scale (ICS).
Time frame: Baseline
Learned Helplessness Scale (LHS)
Time frame: Baseline
Depression, Anxiety, Stress Scale (DASS-21)
Time frame: Baseline
Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).
Time frame: Baseline
Positive And Negative Affect Schedule (PANAS)
Time frame: Baseline
Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
Time frame: Baseline
Emotion Regulation Questionnaire (ERQ
Time frame: Baseline
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 4 Dec 2025.
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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.
Silvia Lo Vecchio principal investigator
Aalborg Universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histamine and Cowhage 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 11 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. 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. 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?
Contact Silvia Lo Vecchio (+4521397785, slv@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring pain by computerized Visual Analog Scale Scoring (time frame: Immediately after the intervention). The study lists 2 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 4 Dec 2025.