Optical Elastography of Systemic Sclerosis Skin

Scleroderma Clinical Trial

Official title:

Optical Elastography of Systemic Sclerosis Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835196
• Other study ID #: HSC-MS-16-0383
• Secondary ID: PR150338
• Status: Completed
• Start date: October 25, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: February 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

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.

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin optical elastography (OCE) scan score		Baseline
Secondary	Skin thickness as assessed by Modified Rodnan Skin Score (mRSS)		Baseline
Secondary	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
Secondary	Disability as assessed by the Scleroderma Health Assessment Questionnaire		Baseline