PruritusPRURITHEQUENCT05678309
Establishment of a Patient Library in Patients With Pruritus Sine Materia
An observational study of Pruritus and Chronic Pruritus, run by University Hospital, Brest at 1 site in France.
Trial summary
Very little is currently known about the pathophysiology of pruritus sine materia according to the etiology. The creation of this cohort should make it possible to improve our clinical and biological knowledge according to the etiology, by collecting blood, skin, feces, and clinical data. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pruritus, Chronic Pruritus, Itch
- What is being tested?
- Blood samples, skin swab sample and skin biopsy sample
- How many people
- 175 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2023to Jun 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with pruritus sine materia
Who may be able to join
- Diagnosis of pruritus sine materia
- Collection of consent
- Adult
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emilie BRENAUT contact
France1 site, 1 recruiting
- Recruiting
Service de dermatologie, CHRU BREST
Brest, 29200
Laurent MISERY, +33 2 98 22 33 15, laurent.misery@chu-brest.fr
About this study
Very little is currently known about the pathophysiology of pruritus sine materia according to the etiology. The creation of this cohort should make it possible to improve our clinical and biological knowledge according to the etiology, by collecting blood, skin, feces, and clinical data.
Read the detailed description
At inclusion, 52.5 ml of blood will be collected, then an additional skin biopsy and a skin swab. Five questionnaires will be filled in by the patient.
At 6 months, then every years for 5 years, the same 5 questionnaires will be collected as well as the clinical data. However, no more biological samples will be collected.
- Conditions
- Pruritus, Chronic Pruritus, Itch
- Being tested
- Blood samples, skin swab sample, skin biopsy sample, Questionnaires
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
At inclusion :
- 52.5 ml of blood :
- 24 ml plasma
- 20 ml serum
- 6 ml DNA
- 2.5 ml RNA
skin swab sampleOther
At inclusion a skin swab sample will be collected
skin biopsy sampleOther
At inclusion a skin biopsy sample will be collected
QuestionnairesOther
At inclusion, at 6 months and every year, the patient will respond to 5 questionnaires : Brest questionnaire, 5-D itch scale, Dermatology Life Quality Index, Itchy Quality of Life and Hospital Anxiety and Depression Scale
| Study group | Role | What they receive |
|---|---|---|
| patient library | Patient with pruritus sine materia Receives: Other: Blood samples; Other: skin swab sample; Other: skin biopsy sample; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical description of the pruritus
Chronology
Measured: 5 years
Clinical description of the pruritus
Intensity
Measured: 5 years
Clinical description of the pruritus
Location
Measured: 5 years
Clinical description of the pruritus
Aggravating and ameliorating factors
Measured: 5 years
Clinical description of the pruritus
Evolution
Measured: 5 years
Clinical description of the pruritus
Scratching
Measured: 5 years
Clinical description of the pruritus
Chronology, intensity, location, aggravating and ameliorating factors, evolution, scratching
Measured: 5 years
5-D itch scale questionnaire
The scores for each of the five domains (duration, degree, direction, disability, ditribution) are calculated separately and then added together to obtain a total 5-D score.
The 5-D score can range from 5 (no pruritus) to 25 (most severe pruritus). Scores with a single item (duration, degree, direction) are equal to the value indicated by the answer choice (from 1 to 5).
The impact of pruritus (disability) includes four items that assess the impact of itching on daily activities: sleep, leisure activities, social activities, domestic activities, work/study. The score for impact is reached by taking the highest score on any of the four items.
For location (distribution), the number of body parts affected is collected (potential sum of 0 to 16) and the sum is classified into 5 scores:
- sum of 0 to 2 = score of 1
- sum of 3 to 5 = score of 2
- sum of 6 to 10 = score of 3
- sum of 11 to 13 = score of 4
- sum of 14 to 16 = score of 5
Measured: 5 years
Dermatology Life Quality Index questionnaire (DLQI)
DLQI = Dermatology Life Quality Index is a ten-item questionnaire. The score ranges from 0 to 30. Each question is rated from 0 to 3. The higher the score, the worse the health status.
Interpretation of DLQI:
DLQI scores 0-1: no effect on patient's life DLQI scores 2-5: small effect on patient's life DLQI scores 6-10: moderate effect on patient's life DLQI scores 11-20: very large effect on patient's life DLQI scores 21-30: extremely large effect on patient's life
Measured: 5 years
Hospital anxiety and depression questionnaire (HAD)
The HAD scale is an instrument to screen for anxiety and depressive disorders. It consists of 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score = 21).
To screen for anxiety and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D)
- 7 or less: no symptomatology
- 8 to 10: doubtful symptomatology
- 11 and more: definite symptomatology.
Measured: 5 years
Brest Questionnaire
The Brest questionnaire is a descriptive tool. No score is calculated.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start16 Jun 2023
- Primary completionJun 2033 (estimated)
- Study completionJun 2033 (estimated)
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 only
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678309
- Sponsor's protocol ID
- 29BRC17.0168
- Acronym
- PRURITHEQUE
- Status last verified
- Jun 2026
- First submitted
- 23 Dec 2022
- Last updated
- 25 Jun 2026
- 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Patient Library in Patients With Pruritus Sine Materia
- ClinicalTrials.gov ID
- NCT05678309
- Acronym / sponsor ID
- PRURITHEQUE / 29BRC17.0168
- Conditions
- Pruritus, Chronic Pruritus, Itch
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- Jun 2033 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 10 Jan 2023 (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.
Very little is currently known about the pathophysiology of pruritus sine materia according to the etiology. The creation of this cohort should make it possible to improve our clinical and biological knowledge according to the etiology, by collecting blood, skin, feces, and clinical data.
Detailed description
At inclusion, 52.5 ml of blood will be collected, then an additional skin biopsy and a skin swab. Five questionnaires will be filled in by the patient.
At 6 months, then every years for 5 years, the same 5 questionnaires will be collected as well as the clinical data. However, no more biological samples will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient library | – | Other: Blood samples, Other: skin swab sample, Other: skin biopsy sample, Other: QuestionnairesPatient with pruritus sine materia |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with pruritus sine materia
Key inclusion criteria (3 listed)
- Diagnosis of pruritus sine materia
- Collection of consent
- Adult
Key exclusion criteria (1 listed)
- Refusal to participate in 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 |
|---|---|---|
| Blood samplesAt inclusion : * 52.5 ml of blood : * 24 ml plasma * 20 ml serum * 6 ml DNA * 2.5 ml RNA | Other | patient library |
| skin swab sampleAt inclusion a skin swab sample will be collected | Other | patient library |
| skin biopsy sampleAt inclusion a skin biopsy sample will be collected | Other | patient library |
| QuestionnairesAt inclusion, at 6 months and every year, the patient will respond to 5 questionnaires : Brest questionnaire, 5-D itch scale, Dermatology Life Quality Index, Itchy Quality of Life and Hospital Anxiety and Depression Scale | Other | patient library |
Primary outcome
Clinical description of the pruritus
Time frame: 5 years
Chronology
Clinical description of the pruritus
Time frame: 5 years
Intensity
Clinical description of the pruritus
Time frame: 5 years
Location
Clinical description of the pruritus
Time frame: 5 years
Aggravating and ameliorating factors
Clinical description of the pruritus
Time frame: 5 years
Evolution
Clinical description of the pruritus
Time frame: 5 years
Scratching
Clinical description of the pruritus
Time frame: 5 years
Chronology, intensity, location, aggravating and ameliorating factors, evolution, scratching
5-D itch scale questionnaire
Time frame: 5 years
The scores for each of the five domains (duration, degree, direction, disability, ditribution) are calculated separately and then added together to obtain a total 5-D score. The 5-D score can range from 5 (no pruritus) to 25 (most severe pruritus). Scores with a single item (duration, degree, direction) are equal to the value indicated by the answer choice (from 1 to 5). The impact of pruritus (disability) includes four items that assess the impact of itching on daily activities: sleep, leisure activities, social activities, domestic activities, work/study. The score for impact is reached by taking the highest score on any of the four items. For location (distribution), the number of body parts affected is collected (potential sum of 0 to 16) and the sum is classified into 5 scores: * sum of 0 to 2 = score of 1 * sum of 3 to 5 = score of 2 * sum of 6 to 10 = score of 3 * sum of 11 to 13 = score of 4 * sum of 14 to 16 = score of 5
Dermatology Life Quality Index questionnaire (DLQI)
Time frame: 5 years
DLQI = Dermatology Life Quality Index is a ten-item questionnaire. The score ranges from 0 to 30. Each question is rated from 0 to 3. The higher the score, the worse the health status. Interpretation of DLQI: DLQI scores 0-1: no effect on patient's life DLQI scores 2-5: small effect on patient's life DLQI scores 6-10: moderate effect on patient's life DLQI scores 11-20: very large effect on patient's life DLQI scores 21-30: extremely large effect on patient's life
Hospital anxiety and depression questionnaire (HAD)
Time frame: 5 years
The HAD scale is an instrument to screen for anxiety and depressive disorders. It consists of 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thus making it possible to obtain two scores (maximum score for each score = 21). To screen for anxiety and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D) * 7 or less: no symptomatology * 8 to 10: doubtful symptomatology * 11 and more: definite symptomatology.
Brest Questionnaire
Time frame: 5 years
The Brest questionnaire is a descriptive tool. No score is calculated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Emilie BRENAUT contact
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 Chronic Pruritus, 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent MISERY (02 98 22 33 15, laurent.misery@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical description of the pruritus (time frame: 5 years). The study lists 11 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 25 Jun 2026.