Trial Outcomes & Findings for Broad Band Light for the Treatment and Prevention of Senile Purpura (NCT NCT03690375)
NCT ID: NCT03690375
Last Updated: 2021-04-13
Results Overview
The number of purpuric lesions 30 days after the last treatment will be subtracted from the number of purpuric lesions at baseline
COMPLETED
NA
10 participants
51 days (Treatments done every 7 days starting on Day 0 and ending on Day 21, then the final outcome was measured 30 days after the last treatment)
2021-04-13
Participant Flow
5 subjects with senile pupura were enrolled in the trial and analyzed. An additional 5 subjects without senile purpura were also enrolled as a control for some secondary measures.
Unit of analysis: arms
Participant milestones
| Measure |
BBL Treatment
One arm was randomly selected to receive treatment with Sciton's BBL according to a protocol with multiple passes with different filters and settings.
|
No Treatment
One arm was not treated
|
|---|---|---|
|
Overall Study
STARTED
|
10 10
|
10 10
|
|
Overall Study
COMPLETED
|
10 10
|
10 10
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only the subjects with senile purpura (5 of 10) were analyzed for measurements of senile purpura
Baseline characteristics by cohort
| Measure |
BBL Treatment
n=5 arms
One arm was randomly selected to receive treatment with Sciton's BBL with multiple passes using a new protocol with varying filters and settings.
|
No Treatment
n=5 arms
One arm was not treated
|
Total
n=10 arms
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=10 Participants • Only the subjects with senile purpura (5 of 10) were analyzed for measurements of senile purpura
|
8 Participants
n=10 Participants • Only the subjects with senile purpura (5 of 10) were analyzed for measurements of senile purpura
|
16 Participants
n=10 Participants • Only the subjects with senile purpura (5 of 10) were analyzed for measurements of senile purpura
|
|
Sex: Female, Male
Male
|
2 Participants
n=10 Participants • Only the subjects with senile purpura (5 of 10) were analyzed for measurements of senile purpura
|
2 Participants
n=10 Participants • Only the subjects with senile purpura (5 of 10) were analyzed for measurements of senile purpura
|
4 Participants
n=10 Participants • Only the subjects with senile purpura (5 of 10) were analyzed for measurements of senile purpura
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
|
Square Area of Purpuric Lesions
|
22.8 cm2
n=5 arms • Measurement of purpuric lesion size was only done in 10 arms (5 participants with senile purpura). The other 5 participants were used as controls for other measures.
|
17.05 cm2
n=5 arms • Measurement of purpuric lesion size was only done in 10 arms (5 participants with senile purpura). The other 5 participants were used as controls for other measures.
|
19.925 cm2
n=10 arms • Measurement of purpuric lesion size was only done in 10 arms (5 participants with senile purpura). The other 5 participants were used as controls for other measures.
|
|
Number of Purpuric Lesions
|
5.8 purpuric lesions
n=5 arms • Only 5 participants (10 arms) were analyzed regarding number of purpuric lesions and size of purpuric lesions. The additional 5 younger subjects were used as to compare changes in mrna and skin thickness but could not be used to measure purpuric lesions as they did not have any.
|
5 purpuric lesions
n=5 arms • Only 5 participants (10 arms) were analyzed regarding number of purpuric lesions and size of purpuric lesions. The additional 5 younger subjects were used as to compare changes in mrna and skin thickness but could not be used to measure purpuric lesions as they did not have any.
|
5.4 purpuric lesions
n=10 arms • Only 5 participants (10 arms) were analyzed regarding number of purpuric lesions and size of purpuric lesions. The additional 5 younger subjects were used as to compare changes in mrna and skin thickness but could not be used to measure purpuric lesions as they did not have any.
|
PRIMARY outcome
Timeframe: 51 days (Treatments done every 7 days starting on Day 0 and ending on Day 21, then the final outcome was measured 30 days after the last treatment)Population: This outcome measure was only assessed in those with purpuric lesions
The number of purpuric lesions 30 days after the last treatment will be subtracted from the number of purpuric lesions at baseline
Outcome measures
| Measure |
BBL Treatment
n=5 Participants
One arm was randomly selected to receive treatment with Sciton's BBL
|
No Treatment
n=5 Participants
One arm was not treated
|
No Treatment No Senile Purpura
Younger control participants without senile purpura
|
|---|---|---|---|
|
The Change From Baseline to 30 Days After the Last Treatment in the Number of Senile Purpura Lesions
|
-3.55 number of purpuric lesions
Interval -12.75 to 0.75
|
-.35 number of purpuric lesions
Interval -8.75 to 4.0
|
—
|
PRIMARY outcome
Timeframe: 51 Days (30 days after the final treatment at Day 21)Population: This measure was only assessed in those with purpuric lesions
The size of the purpuric lesions will be measured by multiplying the height by the width in cm of each lesion and totaling the total cm2 area for each lesion on each arm. Then the total square area 30 days after the last treatment will be subtracted from the total square area at baseline.
Outcome measures
| Measure |
BBL Treatment
n=5 Participants
One arm was randomly selected to receive treatment with Sciton's BBL
|
No Treatment
n=5 Participants
One arm was not treated
|
No Treatment No Senile Purpura
Younger control participants without senile purpura
|
|---|---|---|---|
|
The Change in Total Square Size of Purpuric Lesions From Baseline to 30 Days After the Last Treatment
|
-4.8 cm2
Interval -12.75 to 0.75
|
9.95 cm2
Interval -4.0 to 55.0
|
—
|
SECONDARY outcome
Timeframe: 22 days (1 day after final treatment at day 21)Population: Data collected for those participants with senile purpura for both interventions, data collected for those participants without for only the control no treatment arm
Measurement of epidermal thickness in um as measured by H\&E stained sections using the AxionVision image analysis software based on slides from biopsies taken from the subjects 1 days after their last treatment.
Outcome measures
| Measure |
BBL Treatment
n=5 Participants
One arm was randomly selected to receive treatment with Sciton's BBL
|
No Treatment
n=5 Participants
One arm was not treated
|
No Treatment No Senile Purpura
n=5 Participants
Younger control participants without senile purpura
|
|---|---|---|---|
|
Epidermal Thickness 1 Day After the Fourth BBL Treatment
|
54.89 um
Interval 41.07 to 72.88
|
45.31 um
Interval 25.29 to 70.4
|
53.82 um
Interval 48.48 to 58.47
|
Adverse Events
BBL Treatment
No Treatment
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