Trial Outcomes & Findings for Laser Treatment for the Improvement of Scars and Scleroderma (NCT NCT04567537)
NCT ID: NCT04567537
Last Updated: 2026-04-03
Results Overview
The Vancouver Scar Scale (VSS) is a clinical assessment tool used by healthcare professionals to evaluate the severity and characteristics of scars. It helps clinicians measure how abnormal a scar is compared with normal skin and track changes over time or with treatment. The total score range is 0-13 where a score of 0 indicates normal skin (no abnormal scarring), and a higher score indicates more severe scar features. Therefore, a negative change in Vancouver Score Scale (VCC) post-treatment indicates that the scar improved.
TERMINATED
NA
6 participants
4 months
2026-04-03
Participant Flow
Participant milestones
| Measure |
Hypertrophic Scar
Subjects in this group have hypertrophic scars which are thick, raised scars that form after the skin heals from an injury, such as a cut, burn, surgery, or piercing. It happens when the body produces too much collagen while repairing the skin.
|
Scleroderma
Subject in this group have scleroderma, a chronic autoimmune disease that causes the body to produce too much collagen, leading to fibrosis (thickening and hardening of the tissue).
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|---|---|---|
|
Overall Study
STARTED
|
6
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Hypertrophic Scar
Subjects in this group have hypertrophic scars which are thick, raised scars that form after the skin heals from an injury, such as a cut, burn, surgery, or piercing. It happens when the body produces too much collagen while repairing the skin.
|
Scleroderma
Subject in this group have scleroderma, a chronic autoimmune disease that causes the body to produce too much collagen, leading to fibrosis (thickening and hardening of the tissue).
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Laser Treatment for the Improvement of Scars and Scleroderma
Baseline characteristics by cohort
| Measure |
Scars
n=4 Participants
The entire hypertrophic scar will receive laser treatment only.
Laser Treatment: Patients will receive three laser treatments at one-month intervals.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Vancouver Scar Scale
Subject 1
|
8 number on a scale
n=5 Participants
|
|
Vancouver Scar Scale
Subject 2
|
8 number on a scale
n=5 Participants
|
|
Vancouver Scar Scale
Subject 3
|
6 number on a scale
n=5 Participants
|
|
Vancouver Scar Scale
Subject 4
|
9 number on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsThe Vancouver Scar Scale (VSS) is a clinical assessment tool used by healthcare professionals to evaluate the severity and characteristics of scars. It helps clinicians measure how abnormal a scar is compared with normal skin and track changes over time or with treatment. The total score range is 0-13 where a score of 0 indicates normal skin (no abnormal scarring), and a higher score indicates more severe scar features. Therefore, a negative change in Vancouver Score Scale (VCC) post-treatment indicates that the scar improved.
Outcome measures
| Measure |
Hypertrophic Scar
n=4 Participants
Subjects in this group have hypertrophic scars which are thick, raised scars that form after the skin heals from an injury, such as a cut, burn, surgery, or piercing. It happens when the body produces too much collagen while repairing the skin.
|
|---|---|
|
Change in Vancouver Scar Scale Score Post-Treatment
Subject 3
|
-1 score on a scale
|
|
Change in Vancouver Scar Scale Score Post-Treatment
Subject 1
|
-2 score on a scale
|
|
Change in Vancouver Scar Scale Score Post-Treatment
Subject 2
|
-1 score on a scale
|
|
Change in Vancouver Scar Scale Score Post-Treatment
Subject 4
|
-3 score on a scale
|
Adverse Events
Scars
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Scars
n=6 participants at risk
The entire hypertrophic scar will receive laser treatment only.
Laser Treatment: Patients will receive three laser treatments at one-month intervals.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Post-inflammatory hyperpigmentation
|
16.7%
1/6 • Number of events 1 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place