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SCLERODERMIE: Itch and Clinacal Caracteristics in Systemic Sclerosis

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT03297580
Collaborator
(none)
61
Enrollment
1
Location
1.9
Actual Duration (Months)
31.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Systemic sclerosis (SSc) has heterogeneous symptoms and significant medical morbidity. Recently, itch was described as a symptom of SSc (prevalence of 42,6%). To the investigators knowledge, no study yet has examined the clinical features of itch neither had used a specific itch-related quality of life (QoL) scales in patients with SSc. The objectives were to evaluate the prevalence of pruritus, its characteristics and its impact on the QoL in those patients.

In this descriptive study, patients followed for SSc in the departments of dermatology, rheumatology, internal medicine and pulmonology at the University Hospital of Brest were included. Participants received a questionnaire including questions about the clinical features of pruritus and 2 scores (5-D itch scale, ItchyQol).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    61 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Actual Study Start Date :
    Feb 1, 2016
    Actual Primary Completion Date :
    Mar 31, 2016
    Actual Study Completion Date :
    Mar 31, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Pruritus [Day 1 (questionnaire sent to patient)]

      Pruritus: yes/no

    Secondary Outcome Measures

    1. Characteristics of the systemic sclerosis [Day 1 (questionnaire sent to patient)]

      Duration of the disease

    2. Brest questionnaire [Day 1 (questionnaire sent to patient)]

      questions about the chronology, location, intensity, disruption of daily activities, characteristics of scratching and other associated sensations

    3. 5-D itch scale [Day 1 (questionnaire sent to patient)]

      Validated questionnaire about severity of pruritus using five items (duration, intensity, evolution, impact on daily activities, localisation)

    4. ItchyQol scale [Day 1 (questionnaire sent to patient)]

      questionnaire about quality of life linked to pruritus

    5. Characteristics of the systemic sclerosis [Day 1 (questionnaire sent to patient)]

      treatments,

    6. Characteristics of the systemic sclerosis [Day 1 (questionnaire sent to patient)]

      topography of skin involvement (limited or diffuse systemic sclerosis)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • aged more than 18 years

    • followed for systemic sclerosis since 2000, in the departments of dermatology, rheumatology, internal médicine or pneumology at the University Hospital of Brest.

    Exclusion Criteria:

    • lower than 18 years

    • refusal to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT03297580
    Other Study ID Numbers:
    • SCLERODERMIE
    First Posted:
    Sep 29, 2017
    Last Update Posted:
    Sep 29, 2017
    Last Verified:
    Sep 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Scleroderma, Systemic
    Scleroderma, Diffuse
    Pruritus
    Sclerosis

    Study Results

    No Results Posted as of Sep 29, 2017