Itch and Clinacal Caracteristics in Systemic Sclerosis (SCLERODERMIE)

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).

Study Overview

• Status: Completed
• Conditions: Systemic Sclerosis; Pruritus

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with a systemic sclerosis followed in the University Hospital of Brest

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pruritus	Pruritus: yes/no	Day 1 (questionnaire sent to patient)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of the systemic sclerosis	Duration of the disease	Day 1 (questionnaire sent to patient)
Brest questionnaire	questions about the chronology, location, intensity, disruption of daily activities, characteristics of scratching and other associated sensations	Day 1 (questionnaire sent to patient)
5-D itch scale	Validated questionnaire about severity of pruritus using five items (duration, intensity, evolution, impact on daily activities, localisation)	Day 1 (questionnaire sent to patient)
ItchyQol scale	questionnaire about quality of life linked to pruritus	Day 1 (questionnaire sent to patient)
Characteristics of the systemic sclerosis	treatments,	Day 1 (questionnaire sent to patient)
Characteristics of the systemic sclerosis	topography of skin involvement (limited or diffuse systemic sclerosis)	Day 1 (questionnaire sent to patient)

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): March 31, 2016
• Study Completion (Actual): March 31, 2016

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2017
• Last Update Submitted That Met QC Criteria: September 28, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Skin Manifestations; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse; Pruritus
• Other Study ID Numbers: SCLERODERMIE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No