HistamineNCT06340438
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
A study testing Histamine and Cowhage in people with Histamine and Cowhage, run by Aalborg University at 1 site in Denmark.
Trial summary
This project aims to investigate the relationship between different dimensions of catastrophizing (rumination, magnification, and helplessness) as well as some specific personality traits related to catastrophizing tendencies like anxiety sensitivity and fear sensitivity in the modulation of itch and pain intensities… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Histamine and Cowhage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Apr 2024to 31 Dec 2026
- 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
- Skin diseases (e.g. atopic dermatitis, pruritus nodularis, eczema, psoriasis)
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- 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
- 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. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University
Aalborg, Denmark, 9620
Silvia Lo Vecchio, PhD
About this study
Official title: Investigation of the Neurophysiological and Psychological Aspects of Itch
This project aims to investigate the relationship between different dimensions of catastrophizing (rumination, magnification, and helplessness) as well as some specific personality traits related to catastrophizing tendencies like anxiety sensitivity and fear sensitivity in the modulation of itch and pain intensities in an experimental setting.
Read the detailed description
Chronic itch severely affects the quality of life of patients by interfering with vital functions such as sleep, attention, and sexual activity, with an elevated expression of cognitive and emotional factors such as itch catastrophizing, worrying, as well as personality characteristics such as the predisposition to anxiety, depression, and suicidal thoughts that play an important role in the development, modification, and maintenance of itch. Moreover, chronic itch represents a significant socioeconomic burden due to a prevalence of around 10% in combination with largely suboptimal treatment since limited evidence has been found for the effectiveness of pharmaceutical interventions. The hypothesis of this project is that since it is well documented that the relationship between catastrophizing and pain and that itch and pain share many similarities, investigators can assume the existence of a similar connection between catastrophizing and itching.
- Being tested
- Histamine, Cowhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistamineOther
Histaminergic itch will be evoked by a 1% histamine solution. A droplet of histamine solution will be placed on the predetermined area on the forearm, and the SPT lancet will be pierced through the histamine with 120 g of pressure for 1-2 seconds.
CowhageOther
25 spicules will be inserted in the center of the predefined skin area on the mandibular area. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration.
| Study group | Role | What they receive |
|---|---|---|
| Histamine application | Other | In the first session, the subjects will fill some questionnaires. After that, a squared area of 4x4 cm will be selected at the center of each middle forearm of the subject and cowage or histamine will be applied for 10 minutes, during which the pain/itch following the cowhage/histamine application will be monitored with a VAS scale. After the itch-induction, the subjects will fill in other questionnaire. In second session, the subjects will fill some questionnaires. After that, a squared area of 4x4 cm will be selected at the center of each middle forearm of the subject and cowage or histamine will be applied for 10 minutes, during which the pain/itch following the cowhage/histamine application will be monitored with a VAS scale. After the itch-induction, the subjects will fill out other questionnaires. The order will be randomized, so if the subjects were given the cowhage in the first session, they will receive the histamine application in the second session, and vice versa. Receives: Other: Histamine |
| Cowhage application | Other | In the first session, the subjects will fill some questionnaires. After that, a squared area of 4x4 cm will be selected at the center of each middle forearm of the subject and cowage or histamine will be applied for 10 minutes, during which the pain/itch following the cowhage/histamine application will be monitored with a VAS scale. After the itch-induction, the subjects will fill in other questionnaire. In second session, the subjects will fill some questionnaires. After that, a squared area of 4x4 cm will be selected at the center of each middle forearm of the subject and cowage or histamine will be applied for 10 minutes, during which the pain/itch following the cowhage/histamine application will be monitored with a VAS scale. After the itch-induction, the subjects will fill out other questionnaires. The order will be randomized, so if the subjects were given the cowhage in the first session, they will receive the histamine application in the second session, and vice versa. Receives: Other: Cowhage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).
The Reinforcement Sensitivity Theory - Personality Questionnaire contains the following subscales: the Fight-Flight-Freeze System (FFFS, 10 items); the Behavioral Inhibition System (BIS, 23 items); and the Behavioral Approach System (BAS, 32 items). In total, 65 items have to be answered on a 4-point Likert-type scale ranging from 1 (not at all) to 4 (Highly).
Measured: Baseline 1st session
The Pittsburg Sleep Quality Index (PSQI)
The PSQI consists of 19 items generating seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The seven component scores can be summarized in a global score ranging from zero to 21 with higher scores reflecting a worse overall quality of sleep.
Measured: Baseline 1st session
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 1st session
Positive And Negative Affect Schedule (PANAS)
PANAS measures positive and negative affect dimensions. Positive affects (PA) are defined as "the extent to which a person feels active, enthusiastic, and alert". Negative affect (NA) is a condition of "general distress and unpleasable engagement".
Measured: Baseline 1st session
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: 10 minutes after every itch induction on 1st session
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: 10 minutes after every itch induction on 1st session
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: 10 minutes after every itch induction on 1st session
Positive And Negative Affect Schedule (PANAS)
PANAS measures positive and negative affect dimensions. Positive affects (PA) are defined as "the extent to which a person feels active, enthusiastic, and alert". Negative affect (NA) is a condition of "general distress and unpleasable engagement".
Measured: 10 minutes after every itch induction on 1st session
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 2nd session (3 days after 1st session)
Positive And Negative Affect Schedule (PANAS)
PANAS measures positive and negative affect dimensions. Positive affects (PA) are defined as "the extent to which a person feels active, enthusiastic, and alert". Negative affect (NA) is a condition of "general distress and unpleasable engagement"
Measured: Baseline 2nd session (3 days after 1st session)
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.
Measured: 10 minutes after every itch induction on 2nd session (3 days after 1st session)
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.
Measured: 10 minutes after every itch induction on 2nd session (3 days after 1st session)
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: 10 minutes after every itch induction on 2nd session (3 days after 1st session)
Positive And Negative Affect Schedule (PANAS)
PANAS measures positive and negative affect dimensions. Positive affects (PA) are defined as "the extent to which a person feels active, enthusiastic, and alert". Negative affect (NA) is a condition of "general distress and unpleasable engagement"
Measured: 10 minutes after every itch induction on 2nd session (3 days after 1st session)
Secondary outcomes (2)
Assessment of itch
Immediately following the itch provocations, participants will be instructed to rate the itch intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no itch' and 100 'worst itch imaginable'.
Measured: 1 minute after every itch inductions
Assessment of pain
Immediately following the itch provocations, participants will be instructed to rate the pain intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no pain' and 100 'worst pain imaginable'.
Measured: 1 minute after every itch inductions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start27 Apr 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HistamineStudies 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
- Crossover
- Model description
- The participants will randomly receive applications of cowhage and histamine.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 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
- NCT06340438
- Sponsor's protocol ID
- N-20240004 3rd subproject
- Status last verified
- Nov 2026
- First submitted
- 19 Mar 2024
- Last updated
- 6 Nov 2026
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Neurophysiological and Psychological Aspects of Itch
- ClinicalTrials.gov ID
- NCT06340438
- Acronym / sponsor ID
- N-20240004 3rd subproject
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Apr 2024 (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.
This project aims to investigate the relationship between different dimensions of catastrophizing (rumination, magnification, and helplessness) as well as some specific personality traits related to catastrophizing tendencies like anxiety sensitivity and fear sensitivity in the modulation of itch and pain intensities in an experimental setting.
Detailed description
Chronic itch severely affects the quality of life of patients by interfering with vital functions such as sleep, attention, and sexual activity, with an elevated expression of cognitive and emotional factors such as itch catastrophizing, worrying, as well as personality characteristics such as the predisposition to anxiety, depression, and suicidal thoughts that play an important role in the development, modification, and maintenance of itch. Moreover, chronic itch represents a significant socioeconomic burden due to a prevalence of around 10% in combination with largely suboptimal treatment since limited evidence has been found for the effectiveness of pharmaceutical interventions. The hypothesis of this project is that since it is well documented that the relationship between catastrophizing and pain and that itch and pain share many similarities, investigators can assume the existence of a similar connection between catastrophizing and itching.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The participants will randomly receive applications of cowhage and histamine.
| Arm | Type | Receives |
|---|---|---|
| Histamine application | Other | Other: HistamineIn the first session, the subjects will fill some questionnaires. After that, a squared area of 4x4 cm will be selected at the center of each middle forearm of the subject and cowage or histamine will be applied for 10 minutes, during which the pain/itch following the cowhage/histamine application will be monitored with a VAS scale. After the itch-induction, the subjects will fill in other questionnaire. In second session, the subjects will fill some questionnaires. After that, a squared area of 4x4 cm will be selected at the center of each middle forearm of the subject and cowage or histamine will be applied for 10 minutes, during which the pain/itch following the cowhage/histamine application will be monitored with a VAS scale. After the itch-induction, the subjects will fill out other questionnaires. The order will be randomized, so if the subjects were given the cowhage in the first session, they will receive the histamine application in the second session, and vice versa. |
| Cowhage application | Other | Other: CowhageIn the first session, the subjects will fill some questionnaires. After that, a squared area of 4x4 cm will be selected at the center of each middle forearm of the subject and cowage or histamine will be applied for 10 minutes, during which the pain/itch following the cowhage/histamine application will be monitored with a VAS scale. After the itch-induction, the subjects will fill in other questionnaire. In second session, the subjects will fill some questionnaires. After that, a squared area of 4x4 cm will be selected at the center of each middle forearm of the subject and cowage or histamine will be applied for 10 minutes, during which the pain/itch following the cowhage/histamine application will be monitored with a VAS scale. After the itch-induction, the subjects will fill out other questionnaires. The order will be randomized, so if the subjects were given the cowhage in the first session, they will receive the histamine application in the second session, and vice versa. |
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 (10 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 |
|---|---|---|
| HistamineHistaminergic itch will be evoked by a 1% histamine solution. A droplet of histamine solution will be placed on the predetermined area on the forearm, and the SPT lancet will be pierced through the histamine with 120 g of pressure for 1-2 seconds. | Other | Histamine application |
| Cowhage25 spicules will be inserted in the center of the predefined skin area on the mandibular area. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration. | Other | Cowhage application |
Primary outcome
Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).
Time frame: Baseline 1st session
The Reinforcement Sensitivity Theory - Personality Questionnaire contains the following subscales: the Fight-Flight-Freeze System (FFFS, 10 items); the Behavioral Inhibition System (BIS, 23 items); and the Behavioral Approach System (BAS, 32 items). In total, 65 items have to be answered on a 4-point Likert-type scale ranging from 1 (not at all) to 4 (Highly).
The Pittsburg Sleep Quality Index (PSQI)
Time frame: Baseline 1st session
The PSQI consists of 19 items generating seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The seven component scores can be summarized in a global score ranging from zero to 21 with higher scores reflecting a worse overall quality of sleep.
Depression, Anxiety, Stress Scale (DASS-21)
Time frame: Baseline 1st session
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"
Positive And Negative Affect Schedule (PANAS)
Time frame: Baseline 1st session
PANAS measures positive and negative affect dimensions. Positive affects (PA) are defined as "the extent to which a person feels active, enthusiastic, and alert". Negative affect (NA) is a condition of "general distress and unpleasable engagement".
Pain Catastrophizing Scale (PCS).
Time frame: 10 minutes after every itch induction on 1st session
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).
Itch Catastrophizing Scale (ICS).
Time frame: 10 minutes after every itch induction on 1st session
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).
Learned Helplessness Scale (LHS)
Time frame: 10 minutes after every itch induction on 1st session
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).
Positive And Negative Affect Schedule (PANAS)
Time frame: 10 minutes after every itch induction on 1st session
PANAS measures positive and negative affect dimensions. Positive affects (PA) are defined as "the extent to which a person feels active, enthusiastic, and alert". Negative affect (NA) is a condition of "general distress and unpleasable engagement".
Depression, Anxiety, Stress Scale (DASS-21)
Time frame: Baseline 2nd session (3 days after 1st session)
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"
Positive And Negative Affect Schedule (PANAS)
Time frame: Baseline 2nd session (3 days after 1st session)
PANAS measures positive and negative affect dimensions. Positive affects (PA) are defined as "the extent to which a person feels active, enthusiastic, and alert". Negative affect (NA) is a condition of "general distress and unpleasable engagement"
Pain Catastrophizing Scale (PCS).
Time frame: 10 minutes after every itch induction on 2nd session (3 days after 1st session)
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.
Itch Catastrophizing Scale (ICS).
Time frame: 10 minutes after every itch induction on 2nd session (3 days after 1st session)
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.
Learned Helplessness Scale (LHS)
Time frame: 10 minutes after every itch induction on 2nd session (3 days after 1st session)
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).
Positive And Negative Affect Schedule (PANAS)
Time frame: 10 minutes after every itch induction on 2nd session (3 days after 1st session)
PANAS measures positive and negative affect dimensions. Positive affects (PA) are defined as "the extent to which a person feels active, enthusiastic, and alert". Negative affect (NA) is a condition of "general distress and unpleasable engagement"
2 secondary outcomes
Assessment of itch
Time frame: 1 minute after every itch inductions
Assessment of pain
Time frame: 1 minute after every itch inductions
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.
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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.
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 Histamine and Cowhage, 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 10 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 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. 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, PhD (+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?
Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ). (time frame: Baseline 1st session). The study lists 14 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.