Itch and Clinacal Caracteristics in Systemic Sclerosis | NCT03297580

Studies
Itch and Clinacal Caracteristics in Systemic Sclerosis

NCT03297580

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Sep 29, 2017Actual

Enrollment

61Actual

Phase

Not provided

Conditions

Pruritus
Systemic Sclerosis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2016Actual

Primary Completion Date

Mar 31, 2016Actual

Completion Date

Mar 31, 2016Actual

First Submitted Date

Sep 20, 2017

First Submission Date that Met QC Criteria

Sep 28, 2017

First Posted Date

Sep 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2017

Last Update Posted Date

Sep 29, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest		Brest		29609	France

Condition Browse Module

MeSH Terms

ID	Term
D011537	Pruritus
D012595	Scleroderma, Systemic

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012877	Skin Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided