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OpenTrials
Completed

NCT Number: NCT03297580

Itch and Clinacal Caracteristics in Systemic Sclerosis

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).

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Key information

Conditions

Pruritus Connective Tissue Diseases Pathological Conditions, Signs and Symptoms Scleroderma, Systemic Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Systemic Sclerosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29609, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Pruritus

    Time frame: Day 1 (questionnaire sent to patient)

    Pruritus: yes/no

Secondary outcomes

  1. Characteristics of the systemic sclerosis

    Time frame: Day 1 (questionnaire sent to patient)

    Duration of the disease

  2. Brest questionnaire

    Time frame: 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

    Time frame: 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

    Time frame: Day 1 (questionnaire sent to patient)

    questionnaire about quality of life linked to pruritus

  5. Characteristics of the systemic sclerosis

    Time frame: Day 1 (questionnaire sent to patient)

    treatments,

  6. Characteristics of the systemic sclerosis

    Time frame: Day 1 (questionnaire sent to patient)

    topography of skin involvement (limited or diffuse systemic sclerosis)

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: SCLERODERMIE

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2017
Registry last updated
Sep 29, 2017

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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