Itch and Clinacal Caracteristics in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

— SCLERODERMIE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297580
• Other study ID #: SCLERODERMIE
• Status: Completed
• Phase: N/A
• First received: September 20, 2017
• Last updated: September 28, 2017
• Start date: February 1, 2016
• Est. completion date: March 31, 2016

Study information

• Verified date: September 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 31, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pruritus
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pruritus	Pruritus: yes/no	Day 1 (questionnaire sent to patient)
Secondary	Characteristics of the systemic sclerosis	Duration of the disease	Day 1 (questionnaire sent to patient)
Secondary	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)
Secondary	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)
Secondary	ItchyQol scale	questionnaire about quality of life linked to pruritus	Day 1 (questionnaire sent to patient)
Secondary	Characteristics of the systemic sclerosis	treatments,	Day 1 (questionnaire sent to patient)
Secondary	Characteristics of the systemic sclerosis	topography of skin involvement (limited or diffuse systemic sclerosis)	Day 1 (questionnaire sent to patient)