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Phase Pilot

SSc Arm Fat Quantification Study

  • Study HIC#:2000034678
  • Last Updated:04/25/2024

The purpose of this study is to investigate the relationship between skin fat changes and skin thickening in patients with scleroderma. If you enroll, you will be asked to complete 3 study visits over the course of one year. Each visit will consist of an MRI of the forearm, blood draw, punch skin biopsies, and patient questionnaires.

    Contact Us

    For more information about this study, including how to volunteer, contact:

    Stephanie Perez

    Help Us Discover!

    You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.

    Trial Purpose and Description

    The primary objective of this study is to gain mechanistic insights into the interplay between dermal fibrosis and lipolysis in patients with systemic sclerosis (SSc). The secondary objectives of this study are: To assess the reproducibility of test and retest MRI of the forearm for measuring dermal arm fat in healthy controls and patients with SSc. To determine the association between skin fibrosis as assessed by the modified Rodnan Skin Score (mRSS) and arm fat as assessed by MRI. To test our ability to quantify intradermal fat using computer software applied to MRI arm images compared to gold-standard radiologists quantification. To identify the patient factors that are associated with arm and hand skin and fat atrophy in patients with systemic sclerosis.

    Eligibility Criteria

    In order to be eligible for inclusion in the study, an individual must meet all of the following criteria:

    • Yale scleroderma/systemic sclerosis patient
    • Must be ≥ 18 years old and meet the 2013 American College of Rheumatology criteria for the diagnosis of systemic sclerosis (diffuse or limited)
    • Receiving clinical care at Yale in the Rheumatology and/or Pulmonary clinics
    • Modified Rodnan skin score (mRSS) on forearm of 1, 2 or 3
    • Able to lie prone with one arm held above head for fifteen minutes

    Any individual who meets any of the following criteria will be excluded from participation in this study:

    • Diagnosed with an overlap syndrome (i.e., SLE, RA, etc.) Overlap with polymyositis and/or Sjogren’s syndrome are permitted
    • Unable to provide informed consent.
    • Currently pregnant or nursing.
    • Allergies to lidocaine or epinephrine
    • Diagnosed with bleeding disorder or currently taking blood thinner.

    For more information about this study, including how to volunteer, contact: