Trial Outcomes & Findings for Clinical Evaluation of the Treatment of Spider Angioma (NCT NCT02755467)
NCT ID: NCT02755467
Last Updated: 2023-03-24
Results Overview
Assessment of Baseline vs. 4 weeks post-final treatment for improvement of spider angiomas using the Physician's Global Assessment scale. High scores indicate better outcomes: 0\. None 1. Mild 2. Moderate 3. Significant 4. Very Significant 5. Complete Removal
COMPLETED
NA
22 participants
Four weeks post laser treatment.
2023-03-24
Participant Flow
Participant milestones
| Measure |
Laser Treatment
Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).
KTP laser: Dual Wavelength Laser Emitting 532 nm Laser Energy
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of the Treatment of Spider Angioma
Baseline characteristics by cohort
| Measure |
Laser Treatment
n=22 Participants
Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).
KTP laser: Dual Wavelength Laser Emitting 532 nm Laser Energy
|
|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 19.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Four weeks post laser treatment.Population: 1 subject was lost to follow up
Assessment of Baseline vs. 4 weeks post-final treatment for improvement of spider angiomas using the Physician's Global Assessment scale. High scores indicate better outcomes: 0\. None 1. Mild 2. Moderate 3. Significant 4. Very Significant 5. Complete Removal
Outcome measures
| Measure |
Laser Treatment
n=21 Participants
Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).
KTP laser: Dual Wavelength Laser Emitting 532 nm Laser Energy
|
|---|---|
|
Physician's Global Assessment Scale for Improvement of Spider Angioma
|
4.5 score on a scale
Standard Deviation 0.6
|
Adverse Events
Laser Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Laser Treatment
n=22 participants at risk
Each subject will receive a 532 nm KTP laser treatment for their spider angioma(s).
KTP laser: Dual Wavelength Laser Emitting 532 nm Laser Energy
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
40.9%
9/22 • 4 weeks post final laser treatment
|
|
Skin and subcutaneous tissue disorders
Purpura
|
54.5%
12/22 • 4 weeks post final laser treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place