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Diffuse Cutaneous Scleroderma SFDI Study

This study is investigating a new way to measure skin thickness in people with diffuse cutaneous scleroderma (dSSc), a type of scleroderma where skin hardening affects many body areas. Currently, doctors often use a subjective method called the modified Rodnan skin score (mRSS), which involves feeling the skin. This study is testing a method called Spatial-frequency domain imaging (SFDI), which uses near-infrared light to create detailed images of skin thickness. Researchers want to see if SFDI is a more accurate and objective way to measure changes in your skin over time, and how well it compares to the mRSS. You might be eligible if you are 18 or older and have been diagnosed with dSSc within the last 3 to 5 years, depending on specific criteria.

Study design
This is an interventional study planning to enroll 65 participants. It will compare SFDI measurements with traditional skin thickness assessments.
What's involved
You would have SFDI and mRSS measurements taken at baseline, 3 months, 6 months, and 12 months. Other assessments like ultrasound and skin biopsies may also be performed.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for at least 12 months, with measurements taken at 3, 6, and 12 months after baseline.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07090226

Diffuse Cutaneous Scleroderma (DSSc) SFDI Study

Recruiting
NAAges 18+Interventional
Boston University
~65 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Spatial-frequency domain imaging (SFDI)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Spatial-frequency domain imaging (SFDI) measurements of skin thickness
Measured over Baseline, 3 months, 6 months.12 months
+1 more outcome measured

Conditions

Systemic Scleroderma
Diffuse Cutaneous Scleroderma

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Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Andreea Bujor, MD, PhD · PRINCIPAL_INVESTIGATOR · BU Chobanian & Advesian School of Medicine

Who to contact

Benjamin Chamis
[email protected]
617-358-6792
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Scleroderma (SSc) participants:
Diagnosed with SSc as defined by the American College of Rheumatology within the past 5 years AND fulfill criteria for diffuse cutaneous SSc according to LeRoy classification
Diagnosed with SSc as defined by the American College of Rheumatology within the past 3 years AND have documented evidence of RNA Polymerase III or anti-topoisomerase antibody positivity
Healthy controls must be free of SSc or other autoimmune disease and have no known skin pathology

Exclusion

Diagnosis of skin malignancy within the previous 2 years, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ.
Presence of wounds or skin rashes at the site of Spatial frequency domain imaging (SFDI) measurement or skin biopsy
Presence of other co-morbid illnesses with an estimated median life expectancy \< 5 years.
Subject has known allergy to lidocaine or has had a reaction to local anesthetics in the past will not provide skin biopsy samples at any time during the study.
Subjects who, in the opinion of the investigator, are high-risk for small tissue calcification, or other conditions that may affect wound healing will not provide skin biopsy samples at any time during the study.
Subjects who are pregnant or lactating are excluded from providing a skin biopsy sample only while they are pregnant or lactating.

What this trial measures

  • Spatial-frequency domain imaging (SFDI) measurements of skin thicknessBaseline, 3 months, 6 months.12 months

    SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms. Total SFDI score is defined as the sum of the individual SFDI measurements.

  • Modified Rodnan skin score (mRSS) measurements of skin thicknessBaseline, 3 months, 6 months.12 months

    One of two methods will be used to assess the mRSS: 1) gently pinch the skin using the index finger and thumb, or 2) press the skin between two thumbs to form a fold of skin. to score the 17 body areas on a scale. of 0-3 (0 is normal, 1 is mild thickness, 2 is moderate thickness, and 3 is severe thickness). The range of possible scores is 0 to 51 and a higher total mRSS score generally indicates more severe skin involvement and a worse prognosis in SSc.