NCT02835196

Optical Elastography of Systemic Sclerosis Skin

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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).

Conditions

• Scleroderma

Interventions

Type	Name	Description
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

Timeline

• Start date: 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 across 1 country: United States

Regulatory

• FDA-regulated device study