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NCT Number: NCT07543679

Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Priest-en-Jarez, Pays de la Loire Region, 42270, France

Location status: Recruiting

Location contact

Lucile GRANGE, MD

CONTACT

[email protected]

(0)4 77 82 83 42 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 control patients: Patients without significant skin involvement

Exclusion criteria

  • 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

Treatment and study plan

ADHELASKIN (Tactinnov° - Ecole centrale de Lyon)

Device

Evaluation of stiffness, elastic modulus and pile-up height for ScS patients and controls by ADHELASKIN device

Primary outcomes

  1. 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

Secondary outcomes

  1. Compare skin stiffness in different areas in patients with systemic sclerosis vs. healthy patients

    Time frame: Day 1

    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

  2. Objectively compare skin elasticity in patients with systemic sclerosis vs. healthy patients.

    Time frame: Day 1

    Comparison of the overall and local averages and sums of the elasticity values measured by the ADHELASKIN device in kilopascals (kPA)

  3. Objectively compare skin firmness in patients with systemic sclerosis vs. healthy patients.

    Time frame: Day 1

    Comparison of overall and local averages and sums of firmness values measured by the ADHELASKIN device in micrometers (μm)

  4. Evaluate an association between the stiffness, elasticity, and firmness measurements obtained using the ADHELASKIN device and the mRSS score.

    Time frame: Day 1

    Correlation between skin thickening measured using the mRSS score by a trained investigator and biomechanical measurements of the skin measured by ADHELASKIN

  5. Estimate the patient experience of skin assessment using ADHELASKIN

    Time frame: Day 1

    Standardized patient experience questionnaire in ScS and healthy patients.

  6. Estimate inter-investigator variability in stiffness measurement using ADHELASKIN

    Time frame: Day 1

    Measurement of stiffness in N/m on a small cohort of 10 patients by 2 investigators using ADHELASKIN

  7. Compare the duration of skin stiffness measurement examinations of 17 body regions by mRSS score and using ADHELASKIN

    Time frame: Day 1

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Clara PFENNINGER, PhD

CONTACT

[email protected]

(0)477120287 ext. +33

Lucile GRANGE, MD

CONTACT

[email protected]

(0)4 77 82 83 42 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: OBSKINS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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