Skip to main content
OpenTrials
Completed

NCT Number: NCT02835196

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Skin optical elastography (OCE) scan score

    Time frame: Baseline

Secondary outcomes

  1. Skin thickness as assessed by Modified Rodnan Skin Score (mRSS)

    Time frame: Baseline

  2. Fibrosis score as assessed by forearm skin punch biopsy

    Time frame: Baseline

    A score based on histological findings of skin punch biopsy will be calculated. There some minor risk involved with skin biopsy procedure.

  3. Disability as assessed by the Scleroderma Health Assessment Questionnaire

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • University of Houston

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 15, 2016
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.