ItchNCT04588532
Characterization of BAM8-22 as a New Surrogate Model of Non-histaminergic Itch
A study testing BAM8-22, Histamine and Cowhage (Mucuna Pruriens) in people with Itch, run by Aalborg University at 1 site in Denmark.
Trial summary
With this experiment, the experimenter wish to asses if substance BAM8-22 (Bovine Adrenal Medulla) induce non-histaminergic 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, Histamine and Cowhage (Mucuna Pruriens)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2020to 1 Jun 2021
- 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.
About this study
Official title: Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch
With this experiment, the experimenter wish to asses if substance BAM8-22 (Bovine Adrenal Medulla) induce non-histaminergic itch.
Read the detailed description
With this experiment, the experimenter wish to establish if the substance BAM8-22 (Bovine Adrenal Medulla) induce a non-histaminergic itch by using the antihistamine Doxepin.
The experimenter will also compare itch and the response to antihistamine of BAM8-22, histamine and cowhage.
- Conditions
- Itch
- Being tested
- BAM8-22, Histamine, Cowhage (Mucuna Pruriens), Doxepin
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAM8-22Drug
Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)
HistamineDrug
histamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)
Cowhage (Mucuna Pruriens)Drug
cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)
DoxepinDrug
Doxepin cream (antihistamine) will be applied in 4 areas on the volar forearm
| Study group | Role | What they receive |
|---|---|---|
| doxepin | Experimental | Drug: Doxepin + BAM8-22 Doxepin will be applied for 1.5 hrs followed by the application of BAM8-22. 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
Drug: Doxepin + Histamine Doxepin will be applied for 1.5 hrs followed by the application of Histamine. 20 µl of histamine will be applied to a previously determined area on the volar forearm followed by a prick through the drop
Drug: Doxepin + Cowhage Doxepin will be applied for 1.5 hrs followed by the application of cowhage. 25/35 spicules of cowhage will be inserted in the skin through a gentle rubbing on a previously determined area on the volar forearm followed by a prick through the drop
Drug: Doxepin + Placebo Doxepin will be applied for 1.5 hrs followed by the application of placebo. 20 µl of placebo will be applied to a previously determined area on the volar forearm followed by a prick through the drop Receives: Drug: BAM8-22; Drug: Histamine; Drug: Cowhage (Mucuna Pruriens); Drug: Doxepin |
| itch | Experimental | Drug: BAM8-22 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
Drug: Histamine 20 µl of histamine will be applied to a previously determined area on the volar forearm followed by a prick through the drop
Drug: Cowhage 25/35 spicules of cowhage will be inserted in the skin through a gentle rubbing on a previously determined area on the volar forearm followed by a prick through the drop
Drug: Placebo 20 µl of placebo will be applied to a previously determined area on the volar forearm followed by a prick through the drop Receives: Drug: BAM8-22; Drug: Histamine; Drug: Cowhage (Mucuna Pruriens) |
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
hyperknesis (abnormal pruriceptive state)
is measured by using a mildly 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 posted19 Oct 2020
- Study start1 Oct 2020
- Primary completion1 May 2021
- Study completion1 Jun 2021
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
- 24 participants (actual)
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
- NCT04588532
- Sponsor's protocol ID
- N-20190062 2nd project
- Status last verified
- Jul 2021
- First submitted
- 9 Oct 2020
- Last updated
- 21 Jul 2021
- 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 21 Jul 2021. 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
- NCT04588532
- Acronym / sponsor ID
- N-20190062 2nd project
- Conditions
- Itch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 19 Oct 2020 (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 asses if substance BAM8-22 (Bovine Adrenal Medulla) induce non-histaminergic itch.
Detailed description
With this experiment, the experimenter wish to establish if the substance BAM8-22 (Bovine Adrenal Medulla) induce a non-histaminergic itch by using the antihistamine Doxepin.
The experimenter will also compare itch and the response to antihistamine of BAM8-22, histamine and cowhage.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| doxepin | Experimental | Drug: BAM8-22, Drug: Histamine, Drug: Cowhage (Mucuna Pruriens), Drug: DoxepinDrug: Doxepin + BAM8-22 Doxepin will be applied for 1.5 hrs followed by the application of BAM8-22. 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop Drug: Doxepin + Histamine Doxepin will be applied for 1.5 hrs followed by the application of Histamine. 20 µl of histamine will be applied to a previously determined area on the volar forearm followed by a prick through the drop Drug: Doxepin + Cowhage Doxepin will be applied for 1.5 hrs followed by the application of cowhage. 25/35 spicules of cowhage will be inserted in the skin through a gentle rubbing on a previously determined area on the volar forearm followed by a prick through the drop Drug: Doxepin + Placebo Doxepin will be applied for 1.5 hrs followed by the application of placebo. 20 µl of placebo will be applied to a previously determined area on the volar forearm followed by a prick through the drop |
| itch | Experimental | Drug: BAM8-22, Drug: Histamine, Drug: Cowhage (Mucuna Pruriens)Drug: BAM8-22 20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop Drug: Histamine 20 µl of histamine will be applied to a previously determined area on the volar forearm followed by a prick through the drop Drug: Cowhage 25/35 spicules of cowhage will be inserted in the skin through a gentle rubbing on a previously determined area on the volar forearm followed by a prick through the drop Drug: Placebo 20 µl of placebo will be applied to a previously determined area on the volar forearm followed by a prick through the drop |
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 |
|---|---|---|
| BAM8-22Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin) | Drug | doxepin, itch |
| Histaminehistamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin) | Drug | doxepin, itch |
| Cowhage (Mucuna Pruriens)cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin) | Drug | doxepin, itch |
| DoxepinDoxepin cream (antihistamine) will be applied in 4 areas on the volar forearm | Drug | doxepin |
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
hyperknesis (abnormal pruriceptive state)
Time frame: change from baseline, up to 10 minutes after the first session
is measured by using a mildly 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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
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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 BAM8-22, Histamine and Cowhage (Mucuna Pruriens) 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: finished, as of the sponsor's last update on 21 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 21 Jul 2021.