Trichoscopy for scalp involvement in systemic scleroderma
Prognostic Value of Trichoscopy in Patients With Systemic Scleroderma
University Hospital, Lille · NCT04804930
This study tests whether a quick, noninvasive scalp dermoscopy (trichoscopy) can detect scalp changes in adults with systemic scleroderma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille (other) |
| Locations | 1 site (Lille) |
| Trial ID | NCT04804930 on ClinicalTrials.gov |
What this trial studies
This is an observational study using trichoscopy—a simple, reproducible, noninvasive dermoscopic exam—to document scalp findings in adults who meet the 2013 ACR-EULAR criteria for systemic scleroderma. Investigators will take standardized trichoscopic images and photographs of the scalp and compare those findings with patients' clinical features and systemic disease manifestations. A control group without active inflammatory scalp disease will be used for comparison. Data collection will include clinical history, disease features, and imaging to explore associations between scalp abnormalities and scleroderma characteristics.
Who should consider this trial
Good fit: Adults (≥18) who meet the 2013 ACR-EULAR systemic scleroderma criteria, can give informed consent, and have social insurance coverage are ideal candidates.
Not a fit: People under 18, those under legal protection or deprived of liberty, emergency patients, those unable or unwilling to consent, and control-group participants with active inflammatory scalp disease are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could give patients a simple, noninvasive way to identify and monitor scalp involvement related to systemic scleroderma.
How similar studies have performed: There are few prior studies of trichoscopy specifically in systemic scleroderma, so this approach is relatively novel though trichoscopy itself is well established in dermatology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient who fulfils the Systemic scleroderma ACR-EULAR 2013 criteria * Signed informed consent * Being social insured Exclusion Criteria: * 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
Where this trial is running
Lille
- Hop Claude Huriez Chu Lille — Lille, France (RECRUITING)
Study contacts
- Principal investigator: Vincent Sobanski, MD — University Hospital, Lille
- Study coordinator: Vincent Sobanski, MD
- Email: vincent.sobanski@chru-lille.fr
- Phone: 0320445962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Scleroderma, Systemic, Trichoscopy, Dermoscopy, Systemic Scleroderma, Scalp