Itch and Clinacal Caracteristics in Systemic Sclerosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03297580

Acronym

SCLERODERMIE

Enrollment

Registered

2017-09-29

Start date

2016-02-01

Completion date

2016-03-31

Last updated

2017-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus, Systemic Sclerosis

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Characteristics of the systemic sclerosis	Day 1 (questionnaire sent to patient)	Duration of the disease
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
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

Countries

France

Outcome results