Itch and Clinacal Caracteristics in Systemic Sclerosis

Completed

• Conditions: Pruritus; Systemic Sclerosis

• Registration Number: NCT03297580
• Lead Sponsor: University Hospital, Brest

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-01
• Primary Completion: 2016-03-31
• Study Completion: 2016-03-31
• Status Verified: 2017-09
• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-28
• Last Update Submitted: 2017-09-28
• Study First Posted: 2017-09-29
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pruritus	Day 1 (questionnaire sent to patient)	Pruritus: yes/no

Secondary Outcome Measures

Name	Time	Method
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)
ItchyQol scale	Day 1 (questionnaire sent to patient)	questionnaire about quality of life linked to pruritus
Characteristics of the systemic sclerosis	Day 1 (questionnaire sent to patient)	topography of skin involvement (limited or diffuse systemic sclerosis)
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

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France