An interventional study of ADHELASKIN (Tactinnov° - Ecole centrale de Lyon) in D013493, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Other
Among 132 studies in Scleroderma, Systemic with a site in France — 44 open to participants now, 48 under way, 7 of them phase 3. Scleroderma, Systemic · France.
Among the 132 studies in Scleroderma, Systemic with a site in France, this one is the 27th largest by planned enrollment of the 81 interventional ones, is one of 15 that started in 2026, is one of 35 with no phase, reaches primary completion later than 18 of the 47 other live ones, and was the 123rd registered.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 100 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →44 of the 132 studies in Scleroderma, Systemic with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 144 Scleroderma, Systemic studies recruiting now, 82 (57%) set no upper age limit and 49 (34%) stop at 75 or younger; 19 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →132 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 15 started in 2026.
Median enrollment 75 across the 81 interventional studies, 150 across the 50 observational. Of the 70 that completed or were terminated, 8 (11%) have results posted.
24 of 132 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
Centre Hospitalier Universitaire de Saint Etienne has 1 study filed under Scleroderma, Systemic — fewer than ten, so there is no comparison to draw.
7 of the studies in Scleroderma, Systemic with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925803Phase 3AstraZenecaDetermine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) | 2027-01-06 |
| NCT06655155argenxA Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis | 2027-03 |
| NCT04356755University Hospital, ToulouseSubcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma. | 2027-03 |
| NCT07888842Assistance Publique - Hôpitaux de ParisA Clinical Study on Systemic Sclerosis and the Validation of French-language Questionnaires Assessing Disability, Quality of Life, and Disease Status. | 2027-05 |
| NCT07543679Centre Hospitalier Universitaire de Saint EtienneObjective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis | 2027-05-01 |
Among the 132 studies in Scleroderma, Systemic with a site in France, from their registry updates:
Systemic sclerosis (SSc) is an autoimmune disease characterized by skin fibrosis, which clinically manifests as thickening, hardening, and loss of elasticity of the skin. Patients are typically classified as having diffuse cutaneous SSc (dcSSc) or limited cutaneous SSc (lcSSc) depending on the extent of skin fibrosis. The standard assessment of cutaneous sclerosis is based on the modified Rodnan skin score (mRSS), which consists of clinical palpation of 17 areas of the body, scored from 0 (normal) to 3 (severe sclerosis) for each area, with a total of 51 points.
However, the mRSS has several limitations, including high inter- and intra-observer variability, particularly depending on the clinician's experience, subjectivity of palpation with difficulties in quantifying subtle changes in firmness or elasticity, and limited sensitivity to small changes or in areas that are not severely affected. The assessment of skin fibrosis therefore faces a lack of objective, quantitative tools that are easy to use in routine clinical practice. Certain alternatives have been evaluated (durometer, ultrasound, elastography, etc.), but none has yet been fully adopted or validated for measuring firmness, elasticity, and adhesion at different depths of the skin with good accuracy and reproducibility.
ADHELASKIN° technology (by Tactinnov, LTDS / École Centrale de Lyon) enables objective, highly sensitive measurement of rigidity, firmness and elasticity using an indentation method with a ruby ball sensor. The objective of our study is to assess whether the ADHELASKIN device can differentiate between the biomechanical properties of healthy patients and those of patients with SSc.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with SSc according to the 2013 ACR/EULAR criteria
Device: ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)
Patients without significant skin involvement
Device: ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)
Evaluation of stiffness, elastic modulus and pile-up height for ScS patients and controls by ADHELASKIN device
Objectively compare skin stiffness in patients with systemic sclerosis versus healthy patients
General comparison of average stiffness values in Newtons per meter obtained using the ADHELASKIN device on all areas examined between affected and healthy patients
Time frame: Day 1
Compare skin stiffness in different areas in patients with systemic sclerosis vs. healthy patients
Overall comparison of the sums and local averages and sums of the stiffness ( Newtons per meter) measured by the ADHELASKIN device on all areas explored between affected and healthy patients
Time frame: Day 1
Objectively compare skin elasticity in patients with systemic sclerosis vs. healthy patients.
Comparison of the overall and local averages and sums of the elasticity values measured by the ADHELASKIN device in kilopascals (kPA)
Time frame: Day 1
Objectively compare skin firmness in patients with systemic sclerosis vs. healthy patients.
Comparison of overall and local averages and sums of firmness values measured by the ADHELASKIN device in micrometers (μm)
Time frame: Day 1
Evaluate an association between the stiffness, elasticity, and firmness measurements obtained using the ADHELASKIN device and the mRSS score.
Correlation between skin thickening measured using the mRSS score by a trained investigator and biomechanical measurements of the skin measured by ADHELASKIN
Time frame: Day 1
Estimate the patient experience of skin assessment using ADHELASKIN
Standardized patient experience questionnaire in ScS and healthy patients.
Time frame: Day 1
Estimate inter-investigator variability in stiffness measurement using ADHELASKIN
Measurement of stiffness in N/m on a small cohort of 10 patients by 2 investigators using ADHELASKIN
Time frame: Day 1
Compare the duration of skin stiffness measurement examinations of 17 body regions by mRSS score and using ADHELASKIN
Measurement of the duration of the mRSS examination on the 17 regions and using the ADHELASKIN device on these same regions on 10 patients by a trained investigator
Time frame: Day 1
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for May 2027, 11 months after the start.
Of 94 non-industry interventional studies with no phase under Scleroderma, Systemic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 11 months is below that.
Counting every sponsor, half of 100 studies reached it within 23 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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Centre Hospitalier Universitaire de Saint Etienne →