Scleroderma
Conditions
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).
Interventions
DEVICEOptical 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.
OTHERVisual 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
Sponsors
University of Houston
The University of Texas Health Science Center, Houston
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin optical elastography (OCE) scan score | Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed