Trial Outcomes & Findings for Treatment of Lower Extremity Spider Veins With Excel V (NCT NCT01362192)
NCT ID: NCT01362192
Last Updated: 2015-01-29
Results Overview
A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%)
COMPLETED
PHASE4
20 participants
24 weeks (12 weeks post-final laser treatment)
2015-01-29
Participant Flow
Participant milestones
| Measure |
532 nm KTP Laser Treatment
Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Lower Extremity Spider Veins With Excel V
Baseline characteristics by cohort
| Measure |
532 nm KTP Laser Treatment
n=20 Participants
Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
48 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
I
|
1 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
II
|
15 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
III
|
4 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 24 weeks (12 weeks post-final laser treatment)Population: per protocol
A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%)
Outcome measures
| Measure |
532 nm KTP Laser Treatment
n=16 Participants
Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
|
|---|---|
|
Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments
|
2.5 points on Improvement scale
Interval 1.9 to 2.9
|
SECONDARY outcome
Timeframe: 12 weeks (post-1st laser treatment)Population: per protocol
The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%)
Outcome measures
| Measure |
532 nm KTP Laser Treatment
n=16 Participants
Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
|
|---|---|
|
Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments
|
1.8 points on Improvement scale
Interval 1.0 to 2.4
|
SECONDARY outcome
Timeframe: 24 weeks (12 weeks post-final laser treatment)Population: per protocol
The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%)
Outcome measures
| Measure |
532 nm KTP Laser Treatment
n=16 Participants
Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
|
|---|---|
|
Percent of Subjects With "Significant" or "Very Significant" Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator.
|
69 percent of participants
|
SECONDARY outcome
Timeframe: 24 weeks (12 weeks post-final laser treatment)Population: per protocol
Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Significant Improvement (51 to 75%) * 4 = Very Significant Improvement (76 to 100%)
Outcome measures
| Measure |
532 nm KTP Laser Treatment
n=16 Participants
Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
|
|---|---|
|
Percent of Subjects With "Significant" to "Very Significant" Improvement of Lower Extremity Spider Veins, as Assessed by Subject.
|
75 percent of participants
|
SECONDARY outcome
Timeframe: 24 weeks (12 weeks post-final laser treatment)Population: per protocol
Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale: * 1 = Very Much Not Satisfied * 2 = Not Satisfied * 3 = Somewhat Satisfied * 4 = Satisfied * 5 = Very Much Satisfied
Outcome measures
| Measure |
532 nm KTP Laser Treatment
n=16 Participants
Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
|
|---|---|
|
Percent of Subjects Satisfied With Improvement of Treated Spider Veins.
|
100 percent of participants
|
SECONDARY outcome
Timeframe: Day 0 (1st laser treatment)Population: intent-to-treat
Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).
Outcome measures
| Measure |
532 nm KTP Laser Treatment
n=20 Participants
Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
|
|---|---|
|
Mean Pain Score Associated With Laser Treatment.
|
3.2 Numeric Pain Rating Score
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 12 weeks (2nd laser treatment)Population: intent-to-treat
Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).
Outcome measures
| Measure |
532 nm KTP Laser Treatment
n=20 Participants
Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
|
|---|---|
|
Mean Pain Score Associated With Laser Treatment
|
2.5 Numeric Pain Rating Score
Standard Deviation 0.9
|
Adverse Events
532 nm KTP Laser Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
532 nm KTP Laser Treatment
n=20 participants at risk
Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
|
|---|---|
|
Skin and subcutaneous tissue disorders
Post-Inflammatory Hyperpigmentation at 24 weeks
|
5.0%
1/20 • Number of events 1 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Mild Edema Immediate Post-TX #1
|
35.0%
7/20 • Number of events 7 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Mild Erythema Immediate Post-TX#1
|
55.0%
11/20 • Number of events 11 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Moderate Erythema Post-TX#1
|
40.0%
8/20 • Number of events 8 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Mild Edema Immediate Post-TX#2
|
40.0%
8/20 • Number of events 8 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Moderate Edema Immediate Post-TX#2
|
5.0%
1/20 • Number of events 1 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Mild Erythema Post-TX#2
|
65.0%
13/20 • Number of events 13 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Moderate Erythema Post-TX#2
|
5.0%
1/20 • Number of events 1 • 24 weeks
|
Additional Information
Eric F. Bernstein, M.D., M.S.E.
Main Line Center for Laser Surgery
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place