Trial Outcomes & Findings for Skin Imaging to Inform Laser Treatments (NCT NCT04336163)
NCT ID: NCT04336163
Last Updated: 2024-01-30
Results Overview
Primary outcome variable includes assessment of change in photographed lesion. Two board-certified dermatologists will grade the degree of change of the photographed lesion in quartiles (no change or darkening=0-25, mild lightening=26-50, good lightening=51-75, excellent lightening=76-95, complete resolution=96-100).
TERMINATED
NA
55 participants
Through study completion; average of one year
2024-01-30
Participant Flow
Participant milestones
| Measure |
Prospective Study Group
For the experimental group, the laser surgeon will be exposed to the OCT measurements and will select laser settings and determine treatment parameters based on the measurements.
Optical Coherence Tomography: Skin imaging to determine vascular characteristics such as plexus depth, vessel diameter, and vessel density.
|
Prospective Control Group
For the control group, the laser surgeon will not be exposed to the OCT measurements and will select laser settings and determine treatment parameters based on standard of care, intuition, and experience.
Optical Coherence Tomography: Skin imaging to determine vascular characteristics such as plexus depth, vessel diameter, and vessel density.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
55
|
0
|
Reasons for withdrawal
| Measure |
Prospective Study Group
For the experimental group, the laser surgeon will be exposed to the OCT measurements and will select laser settings and determine treatment parameters based on the measurements.
Optical Coherence Tomography: Skin imaging to determine vascular characteristics such as plexus depth, vessel diameter, and vessel density.
|
Prospective Control Group
For the control group, the laser surgeon will not be exposed to the OCT measurements and will select laser settings and determine treatment parameters based on standard of care, intuition, and experience.
Optical Coherence Tomography: Skin imaging to determine vascular characteristics such as plexus depth, vessel diameter, and vessel density.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
55
|
0
|
Baseline Characteristics
Skin Imaging to Inform Laser Treatments
Baseline characteristics by cohort
| Measure |
Prospective Study Group
n=55 Participants
For the experimental group, the laser surgeon will be exposed to the OCT measurements and will select laser settings and determine treatment parameters based on the measurements.
Optical Coherence Tomography: Skin imaging to determine vascular characteristics such as plexus depth, vessel diameter, and vessel density.
|
Prospective Control Group
For the control group, the laser surgeon will not be exposed to the OCT measurements and will select laser settings and determine treatment parameters based on standard of care, intuition, and experience.
Optical Coherence Tomography: Skin imaging to determine vascular characteristics such as plexus depth, vessel diameter, and vessel density.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=93 Participants
|
—
|
8 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=93 Participants
|
—
|
38 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=93 Participants
|
—
|
9 Participants
n=27 Participants
|
|
Age, Continuous
|
46 years
n=93 Participants
|
—
|
46 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
—
|
15 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=93 Participants
|
—
|
40 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=93 Participants
|
—
|
55 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Through study completion; average of one yearPopulation: 55 experimental group subjects were consented to this study. However, due to the global pandemic, subjects could not come for study visits, which significantly precluded the study team from following up with the subjects for several months. Therefore, the study was terminated. Although we have preoperative photographs, we did not have postoperative photographs of the subjects because we were not able to see them in followup.
Primary outcome variable includes assessment of change in photographed lesion. Two board-certified dermatologists will grade the degree of change of the photographed lesion in quartiles (no change or darkening=0-25, mild lightening=26-50, good lightening=51-75, excellent lightening=76-95, complete resolution=96-100).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion; average of one yearPopulation: 55 experimental group subjects were consented to this study. However, due to the global pandemic, subjects could not come for study visits, which significantly precluded the study team from following up with the subjects for several months. Therefore, the study was terminated.
Any adverse effects of treatment such as scarring, blistering, bruising, and scabbing.
Outcome measures
| Measure |
Prospective Study Group
n=55 Participants
For the experimental group, the laser surgeon will be exposed to the OCT measurements and will select laser settings and determine treatment parameters based on the measurements.
Optical Coherence Tomography: Skin imaging to determine vascular characteristics such as plexus depth, vessel diameter, and vessel density.
|
Prospective Control Group
For the control group, the laser surgeon will not be exposed to the OCT measurements and will select laser settings and determine treatment parameters based on standard of care, intuition, and experience.
Optical Coherence Tomography: Skin imaging to determine vascular characteristics such as plexus depth, vessel diameter, and vessel density.
|
|---|---|---|
|
Number of Participants With Scarring, Blistering, Bruising, and Scabbing
|
0 Participants
|
0 Participants
|
Adverse Events
Prospective Study Group
Prospective Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place