PruritusNCT04399213
Dermal Blood Flow Response to Escalating Doses of Histamine, Administered by a Skin Prick
A study testing 50 µg Histamine, 15 µg Histamine and 5 µg Histamine in people with Pruritus, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
To determine the effective dose and the time course, the dermal blood flow response to histamine will be evaluated at different doses (5 µg, 15 µg and 50 µg). Histamine will be administered by a skin prick on the volar surface of subjects' forearm, alongside a negative control. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pruritus
- What is being tested?
- 50 µg Histamine, 15 µg Histamine and 5 µg Histamine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jan 2019to 19 Feb 2019
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a white male ≥ 18 and ≤ 45 years of age at the time of screening
- Subject is a nonsmoker for at least 6 months prior to the study start
- Subject has a body mass index ≥ 18 and ≤ 30 kg/m2
- Subject is judged to be in good health on the basis of medical history, physical examination and vital signs
- Subject understands the procedures and agrees to comply with them for the entire length of the study by giving written informed consent
Who cannot join
- Subject has excessive hair growth on the volar surface of the forearm
- Subject has a past or present history of diffuse dermatological conditions including eczema, scleroderma, psoriasis, urticaria, dermatographism and dermatitis
- Subject has any abnormality on the skin of the forearm, possibly interfering with the study assessments including tattoos, keloids, tumors, ulcers, burns, flaps and grafts
- Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover the forearms 24 hours before and after each study visit
- Subject currently uses lotions, oils, depilatory preparations, makeup or other topical treatments on the arms and on a regular basis which cannot be discontinued for the duration of the study; subject has used any topical treatments within 7 days of the start of the study
- Subject has a past or present history of (symptomatic) asthma
Show all 17Show fewer
- Subject has a history of severe allergic reactions to food or drugs or adverse experiences of a serious nature related to the administration of either a marketed or investigational drug, including histamine
- Subject currently uses any prescription or nonprescription drugs on a regular basis which cannot be discontinued for the duration of the study; subject has used any prescription or nonprescription medication within 14 days of the start of the study
- Subject is a habitual and heavy consumer of coffee or caffeinated beverages (more than approximately 4 cups of tea, coffee or cola per day) at the time of the study. Subjects who have reduced their consumption to ≤ 4 cups per day at least 1 week prior to enrollment may participate. Subjects who cannot refrain from caffeinated beverages 24 hours before the study visit
- Subject is unable to refrain from drinking alcohol 24 hours prior to histamine application, is currently a regular user (including "recreational use") of any illicit drugs, or has a history of drug (including alcohol) abuse. A drug screen will include amphetamines/ methamphetamines, methylenedioxymethamphetamine, benzodiazepines, barbiturates, cocaine, cannabis, tricyclic antidepressants, methadone and opiates
- Subject cannot refrain from being around second hand smoke 24 hours prior to histamine application or uses nicotine-containing products. Ex-smokers should have ceased smoking at least 6 months prior to screening
- Subject has any of the following vital sign measurements at screening: heart rate ≤ 40 or ≥ 100 beats/min, diastolic blood pressure ≤ 50 or ≥ 89 mmHg and/or systolic Blood Pressure ≤ 90 or ≥ 139 mmHg
- Subject has been involved in testing an investigational drug in another clinical study within the last 4 weeks or 5 half-lives
- Subject has evidence of a clinically significant active infection, fever of 38°C or above at the time of the study visits
- Subject has a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs
- Subject is in a situation or has a condition, which, in the opinion of the investigator, may interfere with safe and optimal participation in the study
- Subject has a history of any illness or disorder, which, in the opinion of the investigator, might confound the results of the study.
Trial locations and contacts
1 site in 1 country.
About this study
To determine the effective dose and the time course, the dermal blood flow response to histamine will be evaluated at different doses (5 µg, 15 µg and 50 µg). Histamine will be administered by a skin prick on the volar surface of subjects' forearm, alongside a negative control. Changes in dermal blood flow will be measured with laser Doppler imaging at different time points following the skin prick.
- Conditions
- Pruritus
- Being tested
- 50 µg Histamine, 15 µg Histamine, 5 µg Histamine, Placebo (saline)
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 µg HistamineProcedure or surgery
Skin prick through 50 µg/5 µL histamine diHCl
15 µg HistamineProcedure or surgery
Skin prick through 15 µg/5 µL histamine diHCl
5 µg HistamineProcedure or surgery
Skin prick through 5 µg/5 µL histamine diHCl
Placebo (saline)Procedure or surgery
Skin prick through 5 µL saline (0.9% NaCl)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | From cubital fossae to wrist: 50 - 15 - 5 µg histamine dihydrochloride Receives: Procedure: 50 µg Histamine; Procedure: 15 µg Histamine; Procedure: 5 µg Histamine; Procedure: Placebo (saline) |
| Group B | Experimental | From cubital fossae to wrist: 15 - 5 - 50 µg histamine dihydrochloride Receives: Procedure: 50 µg Histamine; Procedure: 15 µg Histamine; Procedure: 5 µg Histamine; Procedure: Placebo (saline) |
| Group C | Experimental | From cubital fossae to wrist: 5 - 50 - 15 µg histamine dihydrochloride Receives: Procedure: 50 µg Histamine; Procedure: 15 µg Histamine; Procedure: 5 µg Histamine; Procedure: Placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dermal blood flow induced by histamine skin pricks, compared to baseline and placebo for different doses
Measured: The dermal blood flow will be assessed before (baseline) and every 5 minutes during the hour following the skin pricks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start15 Jan 2019
- Primary completion19 Feb 2019
- Study completion19 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Randomized, double-blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399213
- Sponsor's protocol ID
- CCP18-3305-HIS-Part I
- Status last verified
- May 2020
- First submitted
- 8 Nov 2018
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermal Blood Flow Response to Escalating Doses of Histamine, Administered by a Skin Prick
- ClinicalTrials.gov ID
- NCT04399213
- Acronym / sponsor ID
- CCP18-3305-HIS-Part I
- Conditions
- Pruritus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 22 May 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.
To determine the effective dose and the time course, the dermal blood flow response to histamine will be evaluated at different doses (5 µg, 15 µg and 50 µg). Histamine will be administered by a skin prick on the volar surface of subjects' forearm, alongside a negative control. Changes in dermal blood flow will be measured with laser Doppler imaging at different time points following the skin prick.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, double-blind study
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: 50 µg Histamine, Procedure: 15 µg Histamine, Procedure: 5 µg Histamine, Procedure: Placebo (saline)From cubital fossae to wrist: 50 - 15 - 5 µg histamine dihydrochloride |
| Group B | Experimental | Procedure: 50 µg Histamine, Procedure: 15 µg Histamine, Procedure: 5 µg Histamine, Procedure: Placebo (saline)From cubital fossae to wrist: 15 - 5 - 50 µg histamine dihydrochloride |
| Group C | Experimental | Procedure: 50 µg Histamine, Procedure: 15 µg Histamine, Procedure: 5 µg Histamine, Procedure: Placebo (saline)From cubital fossae to wrist: 5 - 50 - 15 µg histamine dihydrochloride |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is a white male ≥ 18 and ≤ 45 years of age at the time of screening
- Subject is a nonsmoker for at least 6 months prior to the study start
- Subject has a body mass index ≥ 18 and ≤ 30 kg/m2
- Subject is judged to be in good health on the basis of medical history, physical examination and vital signs
- Subject understands the procedures and agrees to comply with them for the entire length of the study by giving written informed consent
Key exclusion criteria (17 listed)
- Subject has excessive hair growth on the volar surface of the forearm
- Subject has a past or present history of diffuse dermatological conditions including eczema, scleroderma, psoriasis, urticaria, dermatographism and dermatitis
- Subject has any abnormality on the skin of the forearm, possibly interfering with the study assessments including tattoos, keloids, tumors, ulcers, burns, flaps and grafts
- Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover the forearms 24 hours before and after each study visit
- Subject currently uses lotions, oils, depilatory preparations, makeup or other topical treatments on the arms and on a regular basis which cannot be discontinued for the duration of the study; subject has used any topical treatments within 7 days of the start of the study
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 |
|---|---|---|
| 50 µg HistamineSkin prick through 50 µg/5 µL histamine diHCl | Procedure or surgery | Group A, Group B, Group C |
| 15 µg HistamineSkin prick through 15 µg/5 µL histamine diHCl | Procedure or surgery | Group A, Group B, Group C |
| 5 µg HistamineSkin prick through 5 µg/5 µL histamine diHCl | Procedure or surgery | Group A, Group B, Group C |
| Placebo (saline)Skin prick through 5 µL saline (0.9% NaCl) | Procedure or surgery | Group A, Group B, Group C |
Primary outcome
Change in dermal blood flow induced by histamine skin pricks, compared to baseline and placebo for different doses
Time frame: The dermal blood flow will be assessed before (baseline) and every 5 minutes during the hour following the skin pricks
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 27 May 2020.
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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 50 µg Histamine, 15 µg Histamine and 5 µg Histamine in people with Pruritus, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 inclusion and 17 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 27 May 2020. 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 Belgium. 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?
Change in dermal blood flow induced by histamine skin pricks, compared to baseline and placebo for different doses (time frame: The dermal blood flow will be assessed before (baseline) and every 5 minutes during the hour following the skin pricks). 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 27 May 2020.