D013493OBSKINSNCT07543679
Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis
A study testing ADHELASKIN (Tactinnov° - Ecole centrale de Lyon) in people with D013493, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- D013493
- What is being tested?
- ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2026to 1 May 2027
- Phase
- Interventional
- 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
Who may be able to join
- Patients affiliated with or eligible for social security
- Patients who have received informed consent about the study and have co-signed, with the investigator, a consent form to participate in the study
- For case patients: Patients with SSc according to the 2013 ACR/EULAR criteria
- For healthy patients: Patients without significant skin lesions who are outpatients or inpatients at a department of the Saint-Etienne University Hospital
- For healthy volunteers: Volunteers without significant skin lesions who work at the Saint-Etienne University Hospital and whose participation in the study does not require any special travel
Who cannot join
- Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than research;
- Adults subject to legal protection measures (guardianship-curatorship) or unable to express their consent
- Inflammatory or scarring dermatoses in different individuals
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
CHU de Saint-Etienne
Saint-Priest-en-Jarez, Pays de la Loire Region, 42270
Lucile GRANGE, MD, (0)4 77 82 83 42 ext. +33, Lucile.GRANGE@chu-st-etienne.fr
About this study
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.
- Conditions
- D013493
- Being tested
- ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)
- Keywords
- Systemic sclerosis, firmness, skin evaluation, Rodnan score, mRSS
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)Device
Evaluation of stiffness, elastic modulus and pile-up height for ScS patients and controls by ADHELASKIN device
| Study group | Role | What they receive |
|---|---|---|
| ScS patients | Experimental | Patients with SSc according to the 2013 ACR/EULAR criteria Receives: Device: ADHELASKIN (Tactinnov° - Ecole centrale de Lyon) |
| Control group | Experimental | Patients without significant skin involvement Receives: Device: ADHELASKIN (Tactinnov° - Ecole centrale de Lyon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (7)
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
Measured: 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)
Measured: 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)
Measured: 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
Measured: Day 1
Estimate the patient experience of skin assessment using ADHELASKIN
Standardized patient experience questionnaire in ScS and healthy patients.
Measured: 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
Measured: 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start7 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for D013493Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucile GRANGE, MD, Principal investigator, Centre hospitalo-universitaire de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543679
- Sponsor's protocol ID
- 26CH041
- Other IDs
- ANSM
- Acronym
- OBSKINS
- Status last verified
- Jul 2026
- First submitted
- 14 Apr 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT07543679
- Acronym / sponsor ID
- OBSKINS / 26CH041
- Conditions
- D013493
- Keywords
- Systemic sclerosis, firmness, skin evaluation, Rodnan score, mRSS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 7 May 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 22 Apr 2026 (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) 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ScS patients | Experimental | Device: ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)Patients with SSc according to the 2013 ACR/EULAR criteria |
| Control group | Experimental | Device: ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)Patients without significant skin involvement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients affiliated with or eligible for social security
- Patients who have received informed consent about the study and have co-signed, with the investigator, a consent form to participate in the study
- For case patients: Patients with SSc according to the 2013 ACR/EULAR criteria
- For healthy patients: Patients without significant skin lesions who are outpatients or inpatients at a department of the Saint-Etienne University Hospital
- For healthy volunteers: Volunteers without significant skin lesions who work at the Saint-Etienne University Hospital and whose participation in the study does not require any special travel
Key exclusion criteria (3 listed)
- Persons deprived of their liberty, hospitalized without consent, hospitalized for purposes other than research;
- Adults subject to legal protection measures (guardianship-curatorship) or unable to express their consent
- Inflammatory or scarring dermatoses in different individuals
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 |
|---|---|---|
| ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)Evaluation of stiffness, elastic modulus and pile-up height for ScS patients and controls by ADHELASKIN device | Device | Control group, ScS patients |
Primary outcome
Objectively compare skin stiffness in patients with systemic sclerosis versus healthy patients
Time frame: Day 1
General comparison of average stiffness values in Newtons per meter obtained using the ADHELASKIN device on all areas examined between affected and healthy patients
7 secondary outcomes
Compare skin stiffness in different areas in patients with systemic sclerosis vs. healthy patients
Time frame: Day 1
Objectively compare skin elasticity in patients with systemic sclerosis vs. healthy patients.
Time frame: Day 1
Objectively compare skin firmness in patients with systemic sclerosis vs. healthy patients.
Time frame: Day 1
Evaluate an association between the stiffness, elasticity, and firmness measurements obtained using the ADHELASKIN device and the mRSS score.
Time frame: Day 1
Estimate the patient experience of skin assessment using ADHELASKIN
Time frame: Day 1
Estimate inter-investigator variability in stiffness measurement using ADHELASKIN
Time frame: Day 1
Compare the duration of skin stiffness measurement examinations of 17 body regions by mRSS score and using ADHELASKIN
Time frame: Day 1
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 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
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.
Lucile GRANGE, MD principal investigator
Centre hospitalo-universitaire de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADHELASKIN (Tactinnov° - Ecole centrale de Lyon) in people with D013493, run by Centre Hospitalier Universitaire de Saint Etienne 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 5 inclusion and 3 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 31 Jul 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 Lucile GRANGE, MD ((0)4 77 82 83 42 ext. +33, Lucile.GRANGE@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objectively compare skin stiffness in patients with systemic sclerosis versus healthy patients (time frame: Day 1). 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 31 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.