Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Physician's Global Assessment Scale |
A score of 0 denotes "No evidence of disease, 100% improvement" and "Completely clear." A score of 1 denotes "Very significant clearance (=90% to 100%); only traces of disease remain" and "Almost Clear." A score of 2 denotes "Significant improvement(=75% to < 90%); some evidence of disease remains" and "Marked Improvement." A score of 3 denotes "Intermediate between slight and marked improvement (=50% to <75%)" and "Moderate Improvement." A score of 4 denotes "Some improvement (=25% to <50%); significant evidence of disease remains" and "Slight Improvement ." A score of 5 denotes "Disease has not changed from baseline (+ or - <25%)" and "No Change." A score of 6 denotes "Disease is worse than at baseline by =25% or more" and "Worse." |
baseline, pre-intervention |
|
Primary |
Physician's Global Assessment Scale |
A score of 0 denotes "No evidence of disease, 100% improvement" and "Completely clear." A score of 1 denotes "Very significant clearance (=90% to 100%); only traces of disease remain" and "Almost Clear." A score of 2 denotes "Significant improvement(=75% to < 90%); some evidence of disease remains" and "Marked Improvement." A score of 3 denotes "Intermediate between slight and marked improvement (=50% to <75%)" and "Moderate Improvement." A score of 4 denotes "Some improvement (=25% to <50%); significant evidence of disease remains" and "Slight Improvement ." A score of 5 denotes "Disease has not changed from baseline (+ or - <25%)" and "No Change." A score of 6 denotes "Disease is worse than at baseline by =25% or more" and "Worse." |
1 month after baseline |
|
Primary |
Physician's Global Assessment Scale |
A score of 0 denotes "No evidence of disease, 100% improvement" and "Completely clear." A score of 1 denotes "Very significant clearance (=90% to 100%); only traces of disease remain" and "Almost Clear." A score of 2 denotes "Significant improvement(=75% to < 90%); some evidence of disease remains" and "Marked Improvement." A score of 3 denotes "Intermediate between slight and marked improvement (=50% to <75%)" and "Moderate Improvement." A score of 4 denotes "Some improvement (=25% to <50%); significant evidence of disease remains" and "Slight Improvement ." A score of 5 denotes "Disease has not changed from baseline (+ or - <25%)" and "No Change." A score of 6 denotes "Disease is worse than at baseline by =25% or more" and "Worse." |
2 months after baseline |
|
Primary |
Physician's Global Assessment Scale |
A score of 0 denotes "No evidence of disease, 100% improvement" and "Completely clear." A score of 1 denotes "Very significant clearance (=90% to 100%); only traces of disease remain" and "Almost Clear." A score of 2 denotes "Significant improvement(=75% to < 90%); some evidence of disease remains" and "Marked Improvement." A score of 3 denotes "Intermediate between slight and marked improvement (=50% to <75%)" and "Moderate Improvement." A score of 4 denotes "Some improvement (=25% to <50%); significant evidence of disease remains" and "Slight Improvement ." A score of 5 denotes "Disease has not changed from baseline (+ or - <25%)" and "No Change." A score of 6 denotes "Disease is worse than at baseline by =25% or more" and "Worse." |
3 months after baseline |
|
Primary |
Physician's Global Assessment Scale |
A score of 0 denotes "No evidence of disease, 100% improvement" and "Completely clear." A score of 1 denotes "Very significant clearance (=90% to 100%); only traces of disease remain" and "Almost Clear." A score of 2 denotes "Significant improvement(=75% to < 90%); some evidence of disease remains" and "Marked Improvement." A score of 3 denotes "Intermediate between slight and marked improvement (=50% to <75%)" and "Moderate Improvement." A score of 4 denotes "Some improvement (=25% to <50%); significant evidence of disease remains" and "Slight Improvement ." A score of 5 denotes "Disease has not changed from baseline (+ or - <25%)" and "No Change." A score of 6 denotes "Disease is worse than at baseline by =25% or more" and "Worse." |
4 months after baseline |
|
Primary |
Physician's Global Assessment Scale |
A score of 0 denotes "No evidence of disease, 100% improvement" and "Completely clear." A score of 1 denotes "Very significant clearance (=90% to 100%); only traces of disease remain" and "Almost Clear." A score of 2 denotes "Significant improvement(=75% to < 90%); some evidence of disease remains" and "Marked Improvement." A score of 3 denotes "Intermediate between slight and marked improvement (=50% to <75%)" and "Moderate Improvement." A score of 4 denotes "Some improvement (=25% to <50%); significant evidence of disease remains" and "Slight Improvement ." A score of 5 denotes "Disease has not changed from baseline (+ or - <25%)" and "No Change." A score of 6 denotes "Disease is worse than at baseline by =25% or more" and "Worse." |
Up to 1 year after baseline |
|
Secondary |
Mouth Handicap in Systemic Sclerosis scale |
To assess facial scleroderma |
Compare baseline to post-procedural |
|
Secondary |
Vancouver Scar Scale |
To assess all scars, facial and non-facial |
Compare baseline to post-procedural |
|
Secondary |
Range of Motion Evaluation |
For non-facial scleroderma to evaluate range of motion of the joint by assessing flexion, extension, supination, and pronation using a goniometer |
Compare baseline to post-procedural |
|