Optical Elastography of Systemic Sclerosis Skin

Completed

• Conditions: Scleroderma
• Interventions: Device: Optical Elastography; Other: Visual Assessment

• Registration Number: NCT02835196
• Lead Sponsor: The University of Texas Health Science Center, Houston

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-15
• Study Start: 2017-10-25
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

• have another skin disease other than systemic sclerosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Optical Elastography Assessment of Skin Thickness	Optical Elastography	-
Visual Assessment of Skin Thickness	Visual Assessment	-

Primary Outcome Measures

Name	Time	Method
Skin optical elastography (OCE) scan score	Baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States