Optical Elastography of Systemic Sclerosis Skin

NCT ID: NCT02835196

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-25

Study Completion Date

2018-11-01

Brief Summary

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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).

Detailed Description

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Conditions

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Scleroderma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Optical Elastography Assessment of Skin Thickness

Optical Elastography

Intervention Type 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.

Visual Assessment of Skin Thickness

Visual Assessment

Intervention Type 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

Interventions

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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.

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Houston

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Shervin Assassi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shervin Assassi, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PR150338

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSC-MS-16-0383

Identifier Type: -

Identifier Source: org_study_id

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