Scleroderma, SystemicTRICHLOSCLERONCT04804930
Trichoscopy and Systemic Scleroderma
An observational study of Scleroderma, Systemic, run by University Hospital, Lille at 1 site in France.
Trial summary
Few data are available on scalp involvement in systemic scleroderma. Few data are available on the association between scalp abnormalities and features of systemic scleroderma Trichoscopy is a simple, reproducible, noninvasive examination that is part of the examination of hairy areas in routine dermatologic practice… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic
- What is being tested?
- picture
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2021to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: patients with systemic scleroderma
Who may be able to join
- Patient who fulfils the Systemic scleroderma ACR-EULAR 2013 criteria
- Signed informed consent
- Being social insured
Who cannot join
- Patients aged less than 18 years old
- patients under legal protection
- patients deprived of their liberty
- patients in emergency situations
- patients who refused or unable to give informed consent
- For the control group: sclap inflammatory disease active the day of the examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hop Claude Huriez Chu Lille
Lille, 59037
0320445962
Vincent Sobansky, MD
About this study
Official title: Prognostic Value of Trichoscopy in Patients With Systemic Scleroderma
- Few data are available on scalp involvement in systemic scleroderma.
- Few data are available on the association between scalp abnormalities and features of systemic scleroderma
- Trichoscopy is a simple, reproducible, noninvasive examination that is part of the examination of hairy areas in routine dermatologic practice
- There is a lack of simple, noninvasive examinations to evaluate patients with systemic scleroderma
The objective will be to evaluate the contribution of trichoscopy in the evaluation of patients with systemic scleroderma
- Conditions
- Scleroderma, Systemic
- Being tested
- picture
- Keywords
- Trichoscopy, Dermoscopy, Systemic Scleroderma, Scalp
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pictureProcedure or surgery
Also called Non-invasive trichoscopy: dermoscopic assessment of the scalp (picture)
We will perform a non-invasive assessment of the scalp with a dermoscope by taking two standardized pictures on the frontal area and the occipital area in order to a blinded analysis of trichoscopic patterns
| Study group | Role | What they receive |
|---|---|---|
| patients with systemic scleroderma | Not described Receives: Procedure: picture | |
| healthy subject | healthy subject without systemic scleroderma or known hair or scalp disease Receives: Procedure: picture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of elementary lesions observed by trichoscopic assessment of the scalp
Comparison of the frequencies of elementary lesions visualized in patients with systemic scleroderma and healthy subjects
Measured: Baseline
Secondary outcomes (3)
Correlation between visceral damage of systemic scleroderma and trichoscopic features
Frequency of visceral damage of systemic scleroderma: pulmonary hypertension, lung fibrosis, kidney failure.
Measured: Baseline
Correlation between global severity of systemic scleroderma and trichoscopic features
Correlation between EUSTAR score, Rodnan score, Medsger's score and trichoscopic features
Measured: Baseline
Correlation between autoimmune profile of sclerodermic patients and trichoscopic features
Correlation of antibodies, inflammatory profile of patients with trichoscopic features.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start8 Nov 2021
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Sobanski, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804930
- Sponsor's protocol ID
- 2018_87
- Other IDs
- 2020-A00566-33
- Acronym
- TRICHLOSCLERO
- Status last verified
- Apr 2026
- First submitted
- 15 Mar 2021
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Trichoscopy in Patients With Systemic Scleroderma
- ClinicalTrials.gov ID
- NCT04804930
- Acronym / sponsor ID
- TRICHLOSCLERO / 2018_87
- Conditions
- Scleroderma, Systemic
- Keywords
- Trichoscopy, Dermoscopy, Systemic Scleroderma, Scalp
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Mar 2021 (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.
- Few data are available on scalp involvement in systemic scleroderma.
- Few data are available on the association between scalp abnormalities and features of systemic scleroderma
- Trichoscopy is a simple, reproducible, noninvasive examination that is part of the examination of hairy areas in routine dermatologic practice
- There is a lack of simple, noninvasive examinations to evaluate patients with systemic scleroderma
The objective will be to evaluate the contribution of trichoscopy in the evaluation of patients with systemic scleroderma
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with systemic scleroderma | – | Procedure: picture |
| healthy subject | – | Procedure: picturehealthy subject without systemic scleroderma or known hair or scalp disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with systemic scleroderma
Key inclusion criteria (3 listed)
- Patient who fulfils the Systemic scleroderma ACR-EULAR 2013 criteria
- Signed informed consent
- Being social insured
Key exclusion criteria (6 listed)
- Patients aged less than 18 years old
- patients under legal protection
- patients deprived of their liberty
- patients in emergency situations
- patients who refused or unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pictureAlso: Non-invasive trichoscopy: dermoscopic assessment of the scalp (picture)We will perform a non-invasive assessment of the scalp with a dermoscope by taking two standardized pictures on the frontal area and the occipital area in order to a blinded analysis of trichoscopic patterns | Procedure or surgery | healthy subject, patients with systemic scleroderma |
Primary outcome
Frequency of elementary lesions observed by trichoscopic assessment of the scalp
Time frame: Baseline
Comparison of the frequencies of elementary lesions visualized in patients with systemic scleroderma and healthy subjects
3 secondary outcomes
Correlation between visceral damage of systemic scleroderma and trichoscopic features
Time frame: Baseline
Correlation between global severity of systemic scleroderma and trichoscopic features
Time frame: Baseline
Correlation between autoimmune profile of sclerodermic patients and trichoscopic features
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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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.
Vincent Sobanski, MD principal investigator
University Hospital, Lille
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 Scleroderma, Systemic, run by University Hospital, Lille 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent Sobanski, MD (0320445962, vincent.sobanski@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of elementary lesions observed by trichoscopic assessment of the scalp (time frame: Baseline). 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 22 Apr 2026; AzTrials last refreshed its copy on 5 Nov 2026.