Trial Outcomes & Findings for Blue vs Red Light During Levulan Based Photodynamic Therapy in Patients With Basal Cell Nevus Syndrome (NCT NCT02157623)
NCT ID: NCT02157623
Last Updated: 2020-07-30
Results Overview
The rate of clearance of existing BCC tumors will be assessed in patients with BCNS, using clinical and photographic measurements. The endpoint will be assessed for tumors in a Red light treatment field and a Blue light treatment field in each patient, and compared (bilateral intrapatient comparison).
COMPLETED
NA
3 participants
6 months
2020-07-30
Participant Flow
Participant milestones
| Measure |
Red Light/Blue Light Participants
Subjects will receive Red Light PDT on one side of the body, and Blue Light PDT to the contralateral side.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blue vs Red Light During Levulan Based Photodynamic Therapy in Patients With Basal Cell Nevus Syndrome
Baseline characteristics by cohort
| Measure |
Red Light / Blue Light Participants
n=3 Participants
Subject will be receive red light PDT on one side of the body, and blue light PDT to the contralateral side after Levulan application
|
|---|---|
|
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
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Three (3) patients with BCNS were enrolled.
The rate of clearance of existing BCC tumors will be assessed in patients with BCNS, using clinical and photographic measurements. The endpoint will be assessed for tumors in a Red light treatment field and a Blue light treatment field in each patient, and compared (bilateral intrapatient comparison).
Outcome measures
| Measure |
Red Light Photodynamic Therapy
n=76 Tumors
One side of patient received red light PDT
|
Blue Light Photodynamic Therapy
n=65 Tumors
The other side of the patient received blue light PDT
|
|---|---|---|
|
Tumor Clearance Rate Following Red or Blue Light PDT
|
87.3 Percentage of tumors cleared
Interval 75.0 to 96.0
|
99 Percentage of tumors cleared
Interval 97.0 to 100.0
|
SECONDARY outcome
Timeframe: Maximum value reported during the illumination periodPain reported by the patient, using a 0-10 Visual Analog Scale (VAS), where 0 is no pain and 10 is maximum pain possible.
Outcome measures
| Measure |
Red Light Photodynamic Therapy
n=3 Participants
One side of patient received red light PDT
|
Blue Light Photodynamic Therapy
n=3 Participants
The other side of the patient received blue light PDT
|
|---|---|---|
|
Pain During Illumination
|
5.6 VAS score value
Standard Error 2.0
|
3.7 VAS score value
Standard Error 1.7
|
SECONDARY outcome
Timeframe: 6 monthsOverall patient satisfaction with the technique will be assessed using a simple survey: 6 = extremely satisfied; 5 = very satisfied; 4 = somewhat satisfied; 3 = somewhat dissatisfied; 2 = very dissatisfied; 1 = extremely dissatisfied.
Outcome measures
| Measure |
Red Light Photodynamic Therapy
n=3 Participants
One side of patient received red light PDT
|
Blue Light Photodynamic Therapy
n=3 Participants
The other side of the patient received blue light PDT
|
|---|---|---|
|
Patient Satisfaction Survey
|
5.3 Scores on the rating scale
Interval 5.0 to 6.0
|
5.6 Scores on the rating scale
Interval 5.0 to 6.0
|
Adverse Events
Red Light Photodynamic Therapy
Blue Light Photodynamic Therapy
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