Optical Elastography of Systemic Sclerosis Skin

NCT02835196 — Completed, 12 participants, The University of Texas Health Science Center, Houston

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT02835196
Status	Completed
Study type	Observational
Enrollment	12 (Actual)
Sponsor	The University of Texas Health Science Center, Houston (Other); collaborators: University of Houston
Conditions	Scleroderma
Interventions	Optical Elastography, Visual Assessment (Device, other)
Dates	start 2017-10-25, primary completion 2018-11-01, completion 2018-11-01, first posted 2016-07-15, last updated 2020-02-25
Locations	1 site in United States

-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).

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Optical Elastography Assessment of Skin Thickness		Device: Optical Elastography
Visual Assessment of Skin Thickness		Other: Visual Assessment

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.
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

+Outcome measures

Primary outcomes

Skin optical elastography (OCE) scan score [Baseline]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
The University of Texas Health Science Center at Houston	Houston, Texas	United States

+Investigators

Shervin Assassi, MD, Principal investigator, The University of Texas Health Science Center, Houston