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Itch is defined as an unpleasant sensation that evokes the desire to scratch. Chronic itch, defined as itch persisting for more that 6 weeks, is a key symptom in many diseases severely affects the quality of life of the affected patients and represents a substantial economic burden for the society. At present, there are no effective treatments for chronic itch diseases. Moreover, chronic itch patients express differences in their genes compared with people who do not suffer from itch.
With this experiment, we wish to analyse differences in genes expression in healthy volunteers who have been exposed to artificial itch from small plant needles from the plant cowhage (mucuna pruriens) and compare them to controls who have not been exposed to itch.
The study takes place over 2 sessions over a period of 2 days. Thirty healthy participants will be randomly allocated into two groups named "active group", treated with active cowhage spicules, and "control group", exposed to inactivated cowhage spicules.
During the 1st session, the participant will fill out a questionnaire including basic information and after participants in the active group will be treated with cowhage spicules for 15 minutes, while participants in the control group will receive the inactivated cowhage spicules. All subjects will be provided with a visual analog scale in which they have to report continuously the sensation of itch and pain on a scale from 0 to 100 for 15 minutes. Before cowhage application, 30 minutes and 3 hours after cowhage application, blood samples will be collected from all participants. The 2nd session will take place 24 h after the 1st session and in this session the final blood sample will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active cowhage | Active Comparator | The participant will receive active cowhage in the forearm. |
|
| Inactive cowhage | Sham Comparator | The participant will receive inactive cowhage in the forearm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sampling | Procedure | Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected |
|
| Measure | Description | Time Frame |
|---|---|---|
| miRNA expression over time | Plasma miRNA evaluation | Before active/inactive cowhage |
| miRNA expression over time | Plasma miRNA evaluation | 30 minutes post-Active/inactive cowhage |
| miRNA expression over time | Plasma miRNA evaluation | 3 hours post-active/inactive cowhage |
| miRNA expression over time | Plasma miRNA evaluation | 24 hours post-active/inactive cowhage |
| Protein expression over time | Plasma protein evaluation | Before active/inactive cowhage |
| Protein expression over time | Plasma protein evaluation | 30 minutes post-active/inactive cowhage |
| Protein expression over time | Plasma protein evaluation | 3 hours post-active/inactive cowhage |
| Protein expression over time | Plasma protein evaluation | 24 hours post-active/inactive cowhage |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of itch: visual analog scale (VAS) | Itch following pruritogens will be monitored for 15 minutes using a computerized 100 mm visual analog scale (eVAS software Aalborg University, Denmark), installed on a tablet. The scale range from 0 (no itch) to 100 (worst imaginable itch). | Immediately after Active/inactive cowhage |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University | Gistrup | 9260 | Denmark |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Two groups of subjects: one group will receive active cowhage spicules (itch inducer) and the other group will receive inactivated cowhage spicules (control)
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The participants are blinded about receiving active or inactive cowhage
| Assessment of pain: visual analog scale (VAS) |
Pain following pruritogen will be monitored for 15 minutes using a computerized 100 mm visual analog scale (eVAS software Aalborg University, Denmark), installed on a tablet. The scale range from 0 (no pain) to 100 (worst imaginable pain). |
| Immediately after Active/inactive cowhage |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |