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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02835196
Other study ID # HSC-MS-16-0383
Secondary ID PR150338
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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