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NCT Number: NCT05678309

Establishment of a Patient Library in Patients With Pruritus Sine Materia

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.

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Key information

Conditions

Pruritus Chronic Pruritus Itch Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refusal to participate in the study

Treatment and study plan

Blood Samples

Other

At inclusion :

  • 52.5 ml of blood :
  • 24 ml plasma
  • 20 ml serum
  • 6 ml DNA
  • 2.5 ml RNA

Skin Swab Sample

Other

At inclusion a skin swab sample will be collected

skin biopsy sample

Other

At inclusion a skin biopsy sample will be collected

questionnaires

Other

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

Primary outcomes

  1. Clinical description of the pruritus

    Time frame: 5 years

    Chronology

  2. Clinical description of the pruritus

    Time frame: 5 years

    Intensity

  3. Clinical description of the pruritus

    Time frame: 5 years

    Location

  4. Clinical description of the pruritus

    Time frame: 5 years

    Aggravating and ameliorating factors

  5. Clinical description of the pruritus

    Time frame: 5 years

    Evolution

  6. Clinical description of the pruritus

    Time frame: 5 years

    Scratching

  7. Clinical description of the pruritus

    Time frame: 5 years

    Chronology, intensity, location, aggravating and ameliorating factors, evolution, scratching

  8. 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

  9. 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

  10. 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.

  11. Brest Questionnaire

    Time frame: 5 years

    The Brest questionnaire is a descriptive tool. No score is calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie BRENAUT

CONTACT

[email protected]

Laurent MISERY

CONTACT

[email protected]

02 98 22 33 15

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: PRURITHEQUE

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
Jan 10, 2023
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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