- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04554888
Characterization of New Human Models of Non-histaminergic Itch and Their Interaction With the TRPM8 Receptor
July 19, 2022 updated by: Silvia Lo Vecchio, Aalborg University
In this experiment the investigators would like to assess if papain induces an itch sensation comparable to the itch sensation induced by cowhage and to confirm that the mechanism of action of papain follows the non-histaminergic pathway.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nordjylland
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Aalborg, Nordjylland, Denmark, 9000
- Aalborg University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy men and women
- 18-60 years
- Speak and understand English
Exclusion Criteria:
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids or other addictive 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.).
- 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
- Moles, scars or tattoos in the area to be treated or tested.
- Hypersensitivity to papaya and mango fruit, cashew nuts, rubber latex
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Doxepin Application
During the session each forearm of the subject will be divided into four squared areas (2.5x2.5 cm), see Figure 4. Four of the areas will be treated with doxepin for 1 hour and 30 minutes (with a patch to deposit 1.2 grams of cream).
Each patch will be covered with Tegaderm I.V., an occlusive, adhesive dressing (3M), for at least 1½ hours 48.
At the end of the pre-treatment period, the patches will be removed and the skin will be cleaned with alcohol.
|
Four of the areas will be treated with doxepin for 1 hour and 30 minutes (with a patch to deposit 1.2 grams of cream).
Each patch will be covered with Tegaderm I.V., an occlusive, adhesive dressing (3M), for at least 1½ hours
|
Experimental: Itch Induction
After Doxepin removal, Then tests with papain, cowhage, histamine or vehicle will be conducted.
Each substance will be randomly applied in two areas, one pretreated with doxepin and one with no pre-treatment.
|
Papain will be applied by 1 SPT prick thought the skin
Histamine will be applied by 1 SPT prick thought the skin
Cowhage spicules are 1-2 mm in length and have diameter of 1-3 µm at their tip.
30-35 spicules are gently rubbed into a 1 cm diameter skin area.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Superficial blood perfusion
Time Frame: 15 minutes
|
Superficial blood perfusion is measured by a Speckle contrast imager (FLPI, Moor Instruments, England).
|
15 minutes
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Measuring itch intensity by computerized Visual Analog Scale Scoring
Time Frame: 15 minutes
|
The subjects will rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable" and similarly for sensations of stinging/pricking and burning, both of which are frequently associated with the sensation of itch.
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15 minutes
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Measuring pain intensity by computerized Visual Analog Scale Scoring
Time Frame: 15 minutes
|
The subjects will rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".
|
15 minutes
|
Measuring Alloknesis
Time Frame: 15 minutes
|
Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 milliNewton of force).
This stimulator is applied 0.5 cm outside the area of itch provocation.
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of Cold Detection Thresholds (CDT)
Time Frame: 15 minutes
|
The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape.
During the first 8 seconds, the temperature decreases 1°C per second from a starting temperature of 32°C until the subject perceives a temperature change (cold sensation) and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s.
A cut-off temperature of 0°C will be used.
|
15 minutes
|
Measurement of Cold PainThresholds (CPT)
Time Frame: 15 minutes
|
The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape.
During the first 8 seconds, the temperature decreases 1°C per second from a starting temperature of 32°C until the subject perceives a temperature change (cold sensation) and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s.
A cut-off temperature of 0°C will be used.
|
15 minutes
|
Measurement of Heat Pain Thresholds (HPT)
Time Frame: 15 minutes
|
The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape.
During the first 8 seconds, the temperature raises 1°C per second from a starting temperature of 32°C until the subject detects a painful sensation and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s.
A cut-off temperature of 52°C will be used.
|
15 minutes
|
Measurement of Warm Detection Thresholds (WDT)
Time Frame: 15 minutes
|
The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape.
During the first 8 seconds, the temperature raises 1°C per second from a starting temperature of 32°C until the subject detects a painful sensation and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s.
A cut-off temperature of 52°C will be used.
|
15 minutes
|
Measurement of Pain to Supra-threshold Heat Stimuli
Time Frame: 15 minutes
|
The tests will be conducted by using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape.
The subjects will have to rate the pain to two suprathreshold heat pain stimuli (starting and ending at 32°C with an increase and decrease of 5°C and 3 s plateau at 50°C).
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15 minutes
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Measurement of Mechanical Pain Thresholds (MPT)
Time Frame: 15 minutes
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This test is conducted using a pin-prick set (Aalborg University, Aalborg).
This test is conducted using a pin-prick set (Aalborg University, Aalborg).easurement of Mechanical Pain Thresholds (MPT)
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15 minutes
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Measurement of Mechanical Pain Sensitivity (MPS)
Time Frame: 15 minutes
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This test is conducted using a pin-prick set (Aalborg University, Aalborg).
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15 minutes
|
Touch Pleasantness (TP)
Time Frame: 15 minutes
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Pleasant touch sensation measured using astandardized sensory brush (SENSELab Brush-05, Somedic AB, Hörby, Sweden) exerting a force of 200 to 400 mN.
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
September 14, 2020
First Submitted That Met QC Criteria
September 14, 2020
First Posted (Actual)
September 18, 2020
Study Record Updates
Last Update Posted (Actual)
July 20, 2022
Last Update Submitted That Met QC Criteria
July 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Psychotropic Drugs
- Antidepressive Agents
- Hypnotics and Sedatives
- Antidepressive Agents, Tricyclic
- Sleep Aids, Pharmaceutical
- Histamine Antagonists
- Histamine Agents
- Histamine Agonists
- Doxepin
- Histamine
Other Study ID Numbers
- N-20200005 2nd project
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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