PruritusSCLERODERMIENCT03297580
Itch and Clinacal Caracteristics in Systemic Sclerosis
An observational study of Pruritus and Systemic Sclerosis, run by University Hospital, Brest at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pruritus, Systemic Sclerosis
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2016to 31 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a systemic sclerosis followed in the University Hospital of Brest
Who may be able to join
- 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.
Who cannot join
- lower than 18 years
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Pruritus, Systemic Sclerosis
- Medical subject headings
- Pruritus, Scleroderma, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus
Pruritus: yes/no
Measured: Day 1 (questionnaire sent to patient)
Secondary outcomes (6)
Characteristics of the systemic sclerosis
Duration of the disease
Measured: 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
Measured: Day 1 (questionnaire sent to patient)
5-D itch scale
Validated questionnaire about severity of pruritus using five items (duration, intensity, evolution, impact on daily activities, localisation)
Measured: Day 1 (questionnaire sent to patient)
ItchyQol scale
questionnaire about quality of life linked to pruritus
Measured: Day 1 (questionnaire sent to patient)
Characteristics of the systemic sclerosis
treatments,
Measured: Day 1 (questionnaire sent to patient)
Characteristics of the systemic sclerosis
topography of skin involvement (limited or diffuse systemic sclerosis)
Measured: Day 1 (questionnaire sent to patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Feb 2016
- Primary completion31 Mar 2016
- Study completion31 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297580
- Sponsor's protocol ID
- SCLERODERMIE
- Acronym
- SCLERODERMIE
- Status last verified
- Sep 2017
- First submitted
- 20 Sep 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Itch and Clinacal Caracteristics in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT03297580
- Acronym / sponsor ID
- SCLERODERMIE / SCLERODERMIE
- Conditions
- Pruritus, Systemic Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a systemic sclerosis followed in the University Hospital of Brest
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- lower than 18 years
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pruritus
Time frame: Day 1 (questionnaire sent to patient)
Pruritus: yes/no
6 secondary outcomes
Characteristics of the systemic sclerosis
Time frame: Day 1 (questionnaire sent to patient)
Brest questionnaire
Time frame: Day 1 (questionnaire sent to patient)
5-D itch scale
Time frame: Day 1 (questionnaire sent to patient)
ItchyQol scale
Time frame: Day 1 (questionnaire sent to patient)
Characteristics of the systemic sclerosis
Time frame: Day 1 (questionnaire sent to patient)
Characteristics of the systemic sclerosis
Time frame: Day 1 (questionnaire sent to patient)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pruritus and Systemic Sclerosis, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pruritus (time frame: Day 1 (questionnaire sent to patient)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.