PruritusPRURINEURONCT05024851
Psychogenic and Neurogenic Components in Patients With Psychogenic or Neuropathic Pruritus
An observational study of Pruritus and Psychogenic Skin Disease, run by University Hospital, Brest at 1 site in France.
Trial summary
Scientific research on pruritus is in intensive development, with significant advances in understanding its pathophysiology. The causes of pruritus are very huge; they can be classified into different categories; we can find dermatological causes, systemic causes, neuropathic or neurological causes, psychogenic or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus, Psychogenic Skin Disease, Neuropathic Pain
- What is being tested?
- Questionnaires
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 25 Aug 2021to 8 Jul 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with neuropathic or psychogenic pruritus consulting in the dermatology department of the CHRU de Brest.
Who may be able to join
- Major (> 18 years old)
- Diagnosis of psychogenic pruritus or neuropathic pruritus made in consultation, in day hospital or in hospital, within the dermatology department at the CHRU de Brest
- Able to understand and agree to sign the information and non-opposition notice
- No opposition of the patient
Who cannot join
- Patient under legal protection (guardianship, curatorship)
- Minor (<18 years old)
- Acute or chronic condition which could limit the patient's ability to the study's participation
- Inability to understand and sign the information and non-opposition notice
- Refusal to give no opposition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychogenic and Neurogenic Components in Patients With Psychogenic or Neuropathic Pruritus : PRURINEURO, a Pilot Study
Scientific research on pruritus is in intensive development, with significant advances in understanding its pathophysiology. The causes of pruritus are very huge; they can be classified into different categories; we can find dermatological causes, systemic causes, neuropathic or neurological causes, psychogenic or even idiopathic causes.
The diagnosis of psychogenic pruritus is often over stated, when no cause is found; therefore, it is important to see what is really relieving from psychic so as not to over-diagnose and adopt a therapy more in line with the real problem of the patient. In daily practice, it seems to have a tendency to separate psychogenic and neurogenic etiologies in the diagnosis of neuropathic or psychogenic pruritus.
Read more
In the case of patients with psychogenic pruritus and neuropathic pruritus, no study has attempted to study the respective part of psychogenic and neurogenic components. Consequently, it would therefore be interesting to assess the areas of superposition and distinction of neuropathic and psychogenic pruritus.
The aim of this pilot study is to assess the psychogenic and neurogenic components of psychogenic pruritus and neuropathic pruritus in order to improve understanding of the mechanism and therefore their management.
The main objective of this study is to highlight the differences and the potential common characteristics between psychogenic and neuropathic pruritus in order to improve the differential diagnosis between these two pathologies.
The secondary objective of this study is to describe the psychogenic and neurogenic characteristics of psychogenic and neuropathic pruritus.
Read the detailed description
PruriNeuro : Non-interventional single-center prospective study organized and practiced on humans for the development of medical knowledge, in which the data are obtained by validated questionnaires.
The duration of participation is estimated at 1 hour.
Questionnaires used :
- Critères diagnostiques du prurit psychogène (Diagnosis criteria of functional itch disorder or psychogenic pruritus, from the French psychodermatology group)
- NP5 questionnaire
- Questionnaire de Brest
- HADS
- TAS-20
- DN4i
- Conditions
- Pruritus, Psychogenic Skin Disease, Neuropathic Pain, Itch
- Being tested
- Questionnaires
- Keywords
- Psychogenic Pruritus, Neuropathic Pruritus, Psychogenic Component, Neurogenic Component
- Medical subject headings
- Pruritus, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Evaluation of the Psychogenic and Neurogenic Components using questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patients with Psychogenic pruritus | Not described Receives: Other: Questionnaires | |
| Patients with Neuropathic Pruritus | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire de Brest
Qualitative assessment of pruritus, specifying the chronology, location, intensity, characteristics and effect on daily activities of the itching induced by pruritus
Measured: at the enrollment
HADS (Hospital Anxiety and Depression Scale)
Total score for Depression or Anxiety 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Measured: at the enrollment
NP5
A score of two criteria out of five is optimal to discriminate Neuropathic pruritus (NP) from Non-NP
Measured: at the enrollment
TAS-20
The TAS-20 is a self-report scale that is comprised of 20 items. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree. There are 5 items that are negatively keyed (items 4, 5, 10, 18 and 19). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
Measured: at the enrollment
DN4i
score equal to or greater than 3 : in favor of neuropathic pruritus
Measured: at the enrollment
Diagnosis criteria of functional itch disorder or psychogenic pruritus, from the French psychodermatology group
three compulsory criteria; Three additional criteria from seven items should also be present
Measured: at the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start25 Aug 2021
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
Why it stopped: DECISION OF THE COORDINATOR
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 University Hospital, BrestThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024851
- Sponsor's protocol ID
- PRURINEURO (29BRC21.0135)
- Acronym
- PRURINEURO
- Status last verified
- Jan 2024
- First submitted
- 23 Aug 2021
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychogenic and Neurogenic Components in Patients With Psychogenic or Neuropathic Pruritus : PRURINEURO, a Pilot Study
- ClinicalTrials.gov ID
- NCT05024851
- Acronym / sponsor ID
- PRURINEURO / PRURINEURO (29BRC21.0135)
- Conditions
- Pruritus, Psychogenic Skin Disease, Neuropathic Pain, Itch
- Keywords
- Psychogenic Pruritus, Neuropathic Pruritus, Psychogenic Component, Neurogenic Component
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: DECISION OF THE COORDINATOR
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 27 Aug 2021 (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.
Scientific research on pruritus is in intensive development, with significant advances in understanding its pathophysiology. The causes of pruritus are very huge; they can be classified into different categories; we can find dermatological causes, systemic causes, neuropathic or neurological causes, psychogenic or even idiopathic causes.
The diagnosis of psychogenic pruritus is often over stated, when no cause is found; therefore, it is important to see what is really relieving from psychic so as not to over-diagnose and adopt a therapy more in line with the real problem of the patient. In daily practice, it seems to have a tendency to separate psychogenic and neurogenic etiologies in the diagnosis of neuropathic or psychogenic pruritus.
In the case of patients with psychogenic pruritus and neuropathic pruritus, no study has attempted to study the respective part of psychogenic and neurogenic components. Consequently, it would therefore be interesting to assess the areas of superposition and distinction of neuropathic and psychogenic pruritus.
The aim of this pilot study is to assess the psychogenic and neurogenic components of psychogenic pruritus and neuropathic pruritus in order to improve understanding of the mechanism and therefore their management.
The main objective of this study is to highlight the differences and the potential common characteristics between psychogenic and neuropathic pruritus in order to improve the differential diagnosis between these two pathologies.
The secondary objective of this study is to describe the psychogenic and neurogenic characteristics of psychogenic and neuropathic pruritus.
Detailed description
PruriNeuro : Non-interventional single-center prospective study organized and practiced on humans for the development of medical knowledge, in which the data are obtained by validated questionnaires.
The duration of participation is estimated at 1 hour.
Questionnaires used :
- Critères diagnostiques du prurit psychogène (Diagnosis criteria of functional itch disorder or psychogenic pruritus, from the French psychodermatology group)
- NP5 questionnaire
- Questionnaire de Brest
- HADS
- TAS-20
- DN4i
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Psychogenic pruritus | – | Other: Questionnaires |
| Patients with Neuropathic Pruritus | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neuropathic or psychogenic pruritus consulting in the dermatology department of the CHRU de Brest.
Key inclusion criteria (4 listed)
- Major (> 18 years old)
- Diagnosis of psychogenic pruritus or neuropathic pruritus made in consultation, in day hospital or in hospital, within the dermatology department at the CHRU de Brest
- Able to understand and agree to sign the information and non-opposition notice
- No opposition of the patient
Key exclusion criteria (5 listed)
- Patient under legal protection (guardianship, curatorship)
- Minor (<18 years old)
- Acute or chronic condition which could limit the patient's ability to the study's participation
- Inability to understand and sign the information and non-opposition notice
- Refusal to give no opposition
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 |
|---|---|---|
| QuestionnairesEvaluation of the Psychogenic and Neurogenic Components using questionnaires | Other | Patients with Neuropathic Pruritus, Patients with Psychogenic pruritus |
Primary outcome
Questionnaire de Brest
Time frame: at the enrollment
Qualitative assessment of pruritus, specifying the chronology, location, intensity, characteristics and effect on daily activities of the itching induced by pruritus
HADS (Hospital Anxiety and Depression Scale)
Time frame: at the enrollment
Total score for Depression or Anxiety 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
NP5
Time frame: at the enrollment
A score of two criteria out of five is optimal to discriminate Neuropathic pruritus (NP) from Non-NP
TAS-20
Time frame: at the enrollment
The TAS-20 is a self-report scale that is comprised of 20 items. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree. There are 5 items that are negatively keyed (items 4, 5, 10, 18 and 19). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
DN4i
Time frame: at the enrollment
score equal to or greater than 3 : in favor of neuropathic pruritus
Diagnosis criteria of functional itch disorder or psychogenic pruritus, from the French psychodermatology group
Time frame: at the enrollment
three compulsory criteria; Three additional criteria from seven items should also be present
Results and safety
The study was stopped early (reason given: DECISION OF THE COORDINATOR). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Pruritus
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch
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?
An observational study of Pruritus and Psychogenic Skin Disease, run by University Hospital, Brest at 1 site in France.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 12 Jan 2024. 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 France. 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 was stopped early (reason given: DECISION OF THE COORDINATOR). Results are not available in the source record.
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?
Questionnaire de Brest (time frame: at the enrollment). The study lists 6 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 12 Jan 2024.