Optical Elastography of Systemic Sclerosis Skin

NCT02835196 | Completed FDA Device

• 2 other identifiers: HSC-MS-16-0383PR150338
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Skin optical elastography (OCE) scan score

  Baseline

Secondary Outcomes (3)

• Skin thickness as assessed by Modified Rodnan Skin Score (mRSS)

  Baseline

• Fibrosis score as assessed by forearm skin punch biopsy

  Baseline

• Disability as assessed by the Scleroderma Health Assessment Questionnaire

  Baseline

Study Arms (2)

Optical Elastography Assessment of Skin Thickness

Device: Optical Elastography

Visual Assessment of Skin Thickness

Other: Visual Assessment

Interventions

Optical Elastography DEVICE

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.

Optical Elastography Assessment of Skin Thickness

Visual Assessment OTHER

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

Visual Assessment of Skin Thickness

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen in clinic.

You may qualify if:

• 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

You may not qualify if:

• have another skin disease other than systemic sclerosis

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• University of Houston: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

skin punch biopsy

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

Ergonomics

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Engineering; Technology, Industry, and Agriculture

Study Officials

• Shervin Assassi, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 15, 2016
• Study Start: October 25, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)