Optical Elastography of Systemic Sclerosis Skin

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).

Study Overview

• Status: Completed
• Conditions: Scleroderma
• Intervention / Treatment: Device: Optical Elastography; Other: Visual Assessment

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients seen in clinic.

Description

Inclusion Criteria for scleroderma patients:

• meet the 2013 American College of Rheumatology and the European League Against Rheumatism (ACR/EULAR) criteria for systemic sclerosis with limited or diffuse cutaneous involvement

Exclusion Criteria:

• have another skin disease other than systemic sclerosis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Optical Elastography Assessment of Skin Thickness	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.
Visual Assessment of Skin Thickness	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Skin optical elastography (OCE) scan score	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin thickness as assessed by Modified Rodnan Skin Score (mRSS)		Baseline
Fibrosis score as assessed by forearm skin punch biopsy	A score based on histological findings of skin punch biopsy will be calculated. There some minor risk involved with skin biopsy procedure.	Baseline
Disability as assessed by the Scleroderma Health Assessment Questionnaire		Baseline

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: University of Houston
• Investigators: Principal Investigator: Shervin Assassi, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 15, 2016

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: HSC-MS-16-0383; PR150338 (Other Grant/Funding Number: Congressionally Directed Medical Research Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes