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Could a simple light scan replace the skin pinch test for scleroderma?

NCT ID NCT05672992

Diagnosis Sponsor: Boston University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new, non-invasive imaging technique called spatial frequency domain imaging (SFDI) to measure skin thickness in people with scleroderma, an autoimmune disease that causes skin hardening. Currently, doctors assess skin fibrosis by pinching the skin, which is subjective and varies between doctors. The study will compare SFDI with standard methods like the modified Rodnan skin score, skin biopsies, and ultrasound over 3 years in 78 participants, including healthy controls. If SFDI works well, it could become a rapid, objective tool for monitoring disease activity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Spatial-frequency domain imaging (SFDI) - a non-invasive light-based imaging device
What this could lead to
If successful, SFDI could become a quick, painless way to track skin fibrosis in scleroderma, replacing imprecise pinch tests and helping doctors monitor disease progression or treatment response.
What could go wrong
This is an early observational study with only 78 participants, so results may not apply to all patients. SFDI might not correlate well with existing measures or prove practical in routine care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

78 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants must meet at least one of the following: * Have SSc as defined by the American College of Rheumatology (SSc subjects only) * Suspected of having SSc based on clinical symptoms as determined by their physician (SSc subjects only) * Defined as a healthy control (does not have SSc or another known disease that in the opinion of the investigator could confound the results) Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic scleroderma

Contacts and locations

Locations

  • Shapiro Outpatient Rheumatology Clinic at Boston Medical Center

    Boston, Massachusetts, 02118, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.