MedTrace Logo

Optical Elastography of Systemic Sclerosis Skin

NCT02835196 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2020-02-25

No results posted yet for this study

Summary

The goal of this study is to develop a new way to assess skin thickness in patients with scleroderma (systemic sclerosis). The study will test how well a new imaging method called optical coherence elastography (OCE) compares to the current clinical method used to estimate skin thickness, the modified Rodnan Skin Score (mRSS).

Conditions

  • Scleroderma

Interventions

DEVICE

Optical Elastography

To image skin thickness, Optical Coherence Elastography (OCE)-scanning of 6 body surface areas will be preformed using the Phase-Stabilized Swept Source Optical Coherence Elastography (PhS-SSOCE) system.

OTHER

Visual Assessment

Skin thickness will be visually assessed clinically in 6 body surface areas using the the modified Rodnan Skin Score (mRSS). The mRSS uses a 0-3 scale, where 0 = normal, 1= mild thickness, 2 = moderate thickness, and 3 = severe thickness

Sponsors & Collaborators

  • University of Houston

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Shervin Assassi, MD · The University of Texas Health Science Center, Houston

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2018-11-01
Completion
2018-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02835196 on ClinicalTrials.gov