An observational study in Pruritus, Chronic Pruritus and Itch, sponsored by University Hospital, Brest. Recruiting at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by University Hospital, Brest · Observational
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.
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.
490 studies on the registry are indexed under Pruritus; 93 are open to participants now.
This study's planned enrollment of 175 is above the median of 128 across 48 observational studies indexed under Pruritus.
Browse Pruritus studies →University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with pruritus sine materia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Refusal to participate in the study
Patient with pruritus sine materia
Other: Blood samples · Other: skin swab sample · Other: skin biopsy sample · Other: Questionnaires
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
At inclusion a skin biopsy sample will be collected
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
Clinical description of the pruritus
Chronology
Time frame: 5 years
Clinical description of the pruritus
Intensity
Time frame: 5 years
Clinical description of the pruritus
Location
Time frame: 5 years
Clinical description of the pruritus
Aggravating and ameliorating factors
Time frame: 5 years
Clinical description of the pruritus
Evolution
Time frame: 5 years
Clinical description of the pruritus
Scratching
Time frame: 5 years
Clinical description of the pruritus
Chronology, intensity, location, aggravating and ameliorating factors, evolution, scratching
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 5 years
Brest Questionnaire
The Brest questionnaire is a descriptive tool. No score is calculated.
Time frame: 5 years
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: Study protocol
Time frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Jun 2033, 120 months after the start.
Of 21 observational studies under Pruritus, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 35. This study's planned 120 months is above that.
How these figures are worked out, and which studies are left out of them.
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