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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03297580
Other study ID # SCLERODERMIE
Secondary ID
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
Health authority
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

Study Design


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)
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