ItchNCT04197440
Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch
A study testing BAM8-22 2mg/ml, BAM8-22 1mg/ml and BAM8-22 0.5 mg/ml in people with Itch, run by Aalborg University at 1 site in Denmark.
Trial summary
With this experiment, the experimenter wish to create a new model of itch based on the substance BAM8-22 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch. 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?
- BAM8-22 2mg/ml, BAM8-22 1mg/ml and BAM8-22 0.5 mg/ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2020to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.)
- Moles, wounds, scars or tattoos in the area to be treated or tested
- Lack of ability to cooperate •
- Current use of medications that may affect the trial such as antihistamines and pain killers.
Show all 9Show fewer
- Skin diseases
- Consumption of alcohol or painkillers 24 hours before the study days and between these - Acute or chronic pain •
- Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aalborg University
Aalborg, 9000
Giulia Erica Aliotta, 50290580, gea@hst.aau.dk
About this study
With this experiment, the experimenter wish to create a new model of itch based on the substance BAM8-22 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch.
Read the detailed description
With this experiment, the experimenter wish to create a new model of itch based on the substance BAM8-22 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch.To explore and validate the dose-response features of a of this new itch model based on BAM8-22.
The experimenter will also characterize the sensory quality and temporary aspects of BAM8-22 skin prick test (SPT) in comparison to the inactivated-cowhage delivery system.
- Conditions
- Itch
- Being tested
- BAM8-22 2mg/ml, BAM8-22 1mg/ml, BAM8-22 0.5 mg/ml, Placebo, BAM8-22 with 1 SPT
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAM8-22 2mg/mlDrug
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
BAM8-22 1mg/mlDrug
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
BAM8-22 0.5 mg/mlDrug
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
PlaceboDrug
20 µl of water will be applied to a previously determined area on the volar forearm followed by a prick through the drop
BAM8-22 with 1 SPTDrug
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 1 prick through the drop
BAM8-22 with 5 SPTDrug
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 5 prick through the drop
BAM8-22 with 25 SPTDrug
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 25 prick through the drop
BAM8-22 with inactivate cowhage spiculesDrug
20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules
| Study group | Role | What they receive |
|---|---|---|
| Bam8-22 | Experimental | Not described Receives: Drug: BAM8-22 2mg/ml; Drug: BAM8-22 1mg/ml; Drug: BAM8-22 0.5 mg/ml; Drug: Placebo |
| SPT pricks | Experimental | Not described Receives: Drug: BAM8-22 with 1 SPT; Drug: BAM8-22 with 5 SPT; Drug: BAM8-22 with 25 SPT; Drug: BAM8-22 with inactivate cowhage spicules |
What is being measured
The primary outcome is the main question the study is designed to answer.
superficial blood perfusion
is measured by a speckle contrast imager (FLPI, Moor Instruments, England)
Measured: change from baseline, up to 10 minutes after the first session
Warm Detection Threshold, and Heat Pain threshold
the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: change from baseline, up to 10 minutes after the first session
Cold Detection Threshold and Cold Pain threshold
the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: change from baseline, up to 10 minutes after the first session
Pain supra-threshold heat Stimuli
the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: change from baseline, up to 10 minutes after the first session
Alloknesis
is measured by using a mildy pruritic, non-painful von Frey filaments of a predetermined intensity (generally 5-30 milliNewton of force)
Measured: change from baseline, up to 10 minutes after the first session
mechanical pain threshold and sensitivity
is performed using a pin-prick set (Aalborg University). The set consists of 8 needles each having a diameter of 0,6 mm and different force applications
Measured: change from baseline, up to 10 minutes after the first session
itch rating
the subject will rate the itch for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates "no itch" and 100 indicates "worst imaginable itch"
Measured: change from baseline, up to 10 minutes after the first session
Secondary outcomes (1)
pain rating
the subject will rate the pain for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates "no pain" and 100 indicates "worst imaginable pain"
Measured: change from baseline, up to 10 minutes after the first session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start15 Jan 2020 (estimated)
- Primary completion15 May 2020 (estimated)
- Study completion15 Dec 2020 (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
- Sequential
- 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, Giulia Erica Aliotta, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197440
- Sponsor's protocol ID
- N-20190062
- Status last verified
- Dec 2019
- First submitted
- 11 Dec 2019
- Last updated
- 17 Dec 2019
- 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 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch
- ClinicalTrials.gov ID
- NCT04197440
- Acronym / sponsor ID
- N-20190062
- Conditions
- Itch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (estimated)
- Primary completion
- 15 May 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 13 Dec 2019 (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.
With this experiment, the experimenter wish to create a new model of itch based on the substance BAM8-22 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch.
Detailed description
With this experiment, the experimenter wish to create a new model of itch based on the substance BAM8-22 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch.To explore and validate the dose-response features of a of this new itch model based on BAM8-22.
The experimenter will also characterize the sensory quality and temporary aspects of BAM8-22 skin prick test (SPT) in comparison to the inactivated-cowhage delivery system.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bam8-22 | Experimental | Drug: BAM8-22 2mg/ml, Drug: BAM8-22 1mg/ml, Drug: BAM8-22 0.5 mg/ml, Drug: Placebo |
| SPT pricks | Experimental | Drug: BAM8-22 with 1 SPT, Drug: BAM8-22 with 5 SPT, Drug: BAM8-22 with 25 SPT, Drug: BAM8-22 with inactivate cowhage spicules |
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 (9 listed)
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids or other drugs
- Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.)
- Moles, wounds, scars or tattoos in the area to be treated or tested
- Lack of ability to cooperate •
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 |
|---|---|---|
| BAM8-22 2mg/ml20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop | Drug | Bam8-22 |
| BAM8-22 1mg/ml20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop | Drug | Bam8-22 |
| BAM8-22 0.5 mg/ml20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop | Drug | Bam8-22 |
| Placebo20 µl of water will be applied to a previously determined area on the volar forearm followed by a prick through the drop | Drug | Bam8-22 |
| BAM8-22 with 1 SPT20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 1 prick through the drop | Drug | SPT pricks |
| BAM8-22 with 5 SPT20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 5 prick through the drop | Drug | SPT pricks |
| BAM8-22 with 25 SPT20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 25 prick through the drop | Drug | SPT pricks |
| BAM8-22 with inactivate cowhage spicules20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules | Drug | SPT pricks |
Primary outcome
superficial blood perfusion
Time frame: change from baseline, up to 10 minutes after the first session
is measured by a speckle contrast imager (FLPI, Moor Instruments, England)
Warm Detection Threshold, and Heat Pain threshold
Time frame: change from baseline, up to 10 minutes after the first session
the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Cold Detection Threshold and Cold Pain threshold
Time frame: change from baseline, up to 10 minutes after the first session
the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Pain supra-threshold heat Stimuli
Time frame: change from baseline, up to 10 minutes after the first session
the tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Alloknesis
Time frame: change from baseline, up to 10 minutes after the first session
is measured by using a mildy pruritic, non-painful von Frey filaments of a predetermined intensity (generally 5-30 milliNewton of force)
mechanical pain threshold and sensitivity
Time frame: change from baseline, up to 10 minutes after the first session
is performed using a pin-prick set (Aalborg University). The set consists of 8 needles each having a diameter of 0,6 mm and different force applications
itch rating
Time frame: change from baseline, up to 10 minutes after the first session
the subject will rate the itch for 10 minutes by using a visual analog scale (VAS) on a tablet. this scale goes from 0 to 100. 0 indicates "no itch" and 100 indicates "worst imaginable itch"
1 secondary outcome
pain rating
Time frame: change from baseline, up to 10 minutes after the first session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAM8-22 2mg/ml, BAM8-22 1mg/ml and BAM8-22 0.5 mg/ml 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 9 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: status not confirmed, as of the sponsor's last update on 17 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulia Erica Aliotta (+45 50290580, gea@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
superficial blood perfusion (time frame: change from baseline, up to 10 minutes after the first session). The study lists 7 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 17 Dec 2019.