NCT03297580

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

2 months

First QC Date

September 20, 2017

Last Update Submit

September 28, 2017

Conditions

PruritusSystemic Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Pruritus

    Pruritus: yes/no

    Day 1 (questionnaire sent to patient)

Secondary Outcomes (6)

  • Characteristics of the systemic sclerosis

    Day 1 (questionnaire sent to patient)

  • Brest questionnaire

    Day 1 (questionnaire sent to patient)

  • 5-D itch scale

    Day 1 (questionnaire sent to patient)

  • ItchyQol scale

    Day 1 (questionnaire sent to patient)

  • Characteristics of the systemic sclerosis

    Day 1 (questionnaire sent to patient)

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • lower than 18 years
  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

PruritusScleroderma, Systemic

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsConnective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 29, 2017

Study Start

February 1, 2016

Primary Completion

March 31, 2016

Study Completion

March 31, 2016

Last Updated

September 29, 2017

Record last verified: 2017-09

Locations

FR(1)