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Establishment of a Patient Library in Patients With Pruritus Sine Materia

Establishment of a Patient Library in Patients With Pruritus Sine Materia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05678309
Acronym
PRURITHEQUE
Enrollment
175
Registered
2023-01-10
Start date
2023-06-16
Completion date
2033-06-01
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pruritus, Itch, Pruritus

Brief 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.

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.

Interventions

OTHERBlood samples

At inclusion : * 52.5 ml of blood : * 24 ml plasma * 20 ml serum * 6 ml DNA * 2.5 ml RNA

At inclusion a skin swab sample will be collected

OTHERskin biopsy sample

At inclusion a skin biopsy sample will be collected

OTHERQuestionnaires

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

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of pruritus sine materia * Collection of consent * Adult

Exclusion criteria

\- Refusal to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Clinical description of the pruritus5 yearsChronology
5-D itch scale questionnaire5 yearsThe 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)5 yearsDLQI = 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)5 yearsThe 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 Questionnaire5 yearsThe Brest questionnaire is a descriptive tool. No score is calculated.

Countries

France

Contacts

CONTACTLaurent MISERY
laurent.misery@chu-brest.fr02 98 22 33 15
CONTACTEmilie BRENAUT
emilie.brenaut@chu-brest.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026