Establishment of a Patient Library in Patients With Pruritus Sine Materia
- Conditions
- Chronic PruritusPruritusItch
- Interventions
- Other: Blood samplesOther: skin swab sampleOther: skin biopsy sampleOther: Questionnaires
- Registration Number
- NCT05678309
- Lead Sponsor
- University Hospital, Brest
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 175
- Diagnosis of pruritus sine materia
- Collection of consent
- Adult
- Refusal to participate in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patient library Blood samples Patient with pruritus sine materia patient library skin swab sample Patient with pruritus sine materia patient library skin biopsy sample Patient with pruritus sine materia patient library Questionnaires Patient with pruritus sine materia
- Primary Outcome Measures
Name Time Method Dermatology Life Quality Index questionnaire (DLQI) 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 lifeHospital anxiety and depression questionnaire (HAD) 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.Clinical description of the pruritus 5 years Chronology, intensity, location, aggravating and ameliorating factors, evolution, scratching
5-D itch scale questionnaire 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 5Brest Questionnaire 5 years The Brest questionnaire is a descriptive tool. No score is calculated.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Service de dermatologie, CHRU BREST
🇫🇷Brest, France