Trial Outcomes & Findings for Phase I Photodynamic Therapy (PDT) for Benign Dermal Neurofibromas (NF1) (NCT NCT01682811)
NCT ID: NCT01682811
Last Updated: 2021-06-18
Results Overview
The average fluorescence value for PpIX positive tumor areas in excised, sectioned tumors, as determined by fluorescence microscopy. PpIX signals were detected with excitation at 405 nm and emission with a 600 nm long pass filter. PpIX positive areas were determined to be those exhibiting fluorescence above background levels.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
24 hours
Results posted on
2021-06-18
Participant Flow
A prospective, controlled, nonrandomized phase I clinical trial was conducted between March 2012 and July 2016. This study included adult patients from Froedtert Hospital in Milwaukee, Wisconsin. NF1 patients were recruited through referral by their physician.
Unit of analysis: lesions
Participant milestones
| Measure |
Part 1 Levulan Injection
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) injection and 3 hr incubation, and by Levulan treated lesions after 3 or 24 hr incubation.
|
Part 1 Levulan Painting
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 3 hr incubation, and by Levulan treated lesions and 3 or 24 hr incubation.
|
Experimental: Part 1 Levulan Painted Twice
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation.
|
Part 1 Levulan Painted Twice With Microneedling
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation. All lesions prepared with microneedling.
|
Part 2 Dose Level 1 50 J/cm^2
Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1 - 50 J/cm\^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
|
Part 2 Dose Level 2 100 J/cm^2
Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 2 - 100 J/cm\^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
|
Part 2 Dose Level 3 200 J/cm^2
Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 3 - 200 J/cm\^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Levulan Injection
STARTED
|
1 9
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Injection
Control
|
1 3
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Injection
Treated 3 Hours
|
1 3
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Injection
Treated 24 Hours
|
1 3
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Injection
COMPLETED
|
1 9
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Injection
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Painting
STARTED
|
0 0
|
1 9
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Painting
Control
|
0 0
|
1 3
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Painting
Treated 3 Hours
|
0 0
|
1 3
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Painting
Treated 24 Hours
|
0 0
|
1 3
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Painting
COMPLETED
|
0 0
|
1 9
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Painting
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Painted Twice
STARTED
|
0 0
|
0 0
|
2 12
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Painted Twice
Control
|
0 0
|
0 0
|
2 6
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Painted Twice
Treated 24 Hours
|
0 0
|
0 0
|
2 6
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Painted Twice
COMPLETED
|
0 0
|
0 0
|
2 12
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Painted Twice
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Paint Twice Microneedling
STARTED
|
0 0
|
0 0
|
0 0
|
2 12
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Paint Twice Microneedling
Control
|
0 0
|
0 0
|
0 0
|
2 6
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Paint Twice Microneedling
Treated 24 Hours
|
0 0
|
0 0
|
0 0
|
2 6
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Paint Twice Microneedling
COMPLETED
|
0 0
|
0 0
|
0 0
|
2 12
|
0 0
|
0 0
|
0 0
|
|
Part 1 Levulan Paint Twice Microneedling
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 2 Dose Level 1
STARTED
|
0 0
|
0 0
|
0 0
|
0 0
|
11 60
|
0 0
|
0 0
|
|
Part 2 Dose Level 1
Control
|
0 0
|
0 0
|
0 0
|
0 0
|
10 30
|
0 0
|
0 0
|
|
Part 2 Dose Level 1
Treated
|
0 0
|
0 0
|
0 0
|
0 0
|
10 30
|
0 0
|
0 0
|
|
Part 2 Dose Level 1
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 2 Dose Level 1
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
11 60
|
0 0
|
0 0
|
|
Part 2 Dose Level 2
STARTED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
3 18
|
0 0
|
|
Part 2 Dose Level 2
Control
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
3 9
|
0 0
|
|
Part 2 Dose Level 2
Treated
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
3 9
|
0 0
|
|
Part 2 Dose Level 2
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 2 Dose Level 2
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
3 18
|
0 0
|
|
Part 2 Dose Level 3
STARTED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 2 Dose Level 3
Control
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 2 Dose Level 3
Treated
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 2 Dose Level 3
COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Part 2 Dose Level 3
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
| Measure |
Part 1 Levulan Injection
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) injection and 3 hr incubation, and by Levulan treated lesions after 3 or 24 hr incubation.
|
Part 1 Levulan Painting
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 3 hr incubation, and by Levulan treated lesions and 3 or 24 hr incubation.
|
Experimental: Part 1 Levulan Painted Twice
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation.
|
Part 1 Levulan Painted Twice With Microneedling
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation. All lesions prepared with microneedling.
|
Part 2 Dose Level 1 50 J/cm^2
Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1 - 50 J/cm\^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
|
Part 2 Dose Level 2 100 J/cm^2
Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 2 - 100 J/cm\^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
|
Part 2 Dose Level 3 200 J/cm^2
Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 3 - 200 J/cm\^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Dose Level 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 2 Dose Level 1
Protocol Violation
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
|
Part 2 Dose Level 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
|
Part 2 Dose Level 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental: Part 1 Levulan Injection
n=9 lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) injection and 3 hr incubation, and by Levulan treated lesions after 3 or 24 hr incubation.
|
Part 1 Levulan Painting
n=9 lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 3 hr incubation, and by Levulan treated lesions and 3 or 24 hr incubation.
|
Part 1 Levulan Painted Twice
n=12 lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation.
|
Part 1 Levulan Painted Twice With Microneedling
n=12 lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice or by Levulan treated lesions twice and 24 hr incubation. All lesions prepared with microneedling.
|
Part 2 Dose Level 1 50 J/cm^2
n=60 lesions
Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1 - 50 J/cm\^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
|
Part 2 Dose Level 2 100 J/cm^2
n=18 lesions
Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 2 - 100 J/cm\^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
|
Part 2 Dose Level 3 200 J/cm^2
Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 3 - 200 J/cm\^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
|
Total
n=120 lesions
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=3 Participants
|
0 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
7 Participants
n=11 Participants
|
2 Participants
n=3 Participants
|
0 Participants
|
13 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
4 Participants
n=11 Participants
|
1 Participants
n=3 Participants
|
0 Participants
|
7 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
8 Participants
n=11 Participants
|
1 Participants
n=3 Participants
|
0 Participants
|
13 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=11 Participants
|
2 Participants
n=3 Participants
|
0 Participants
|
7 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
1 participants
n=1 Participants
|
2 participants
n=2 Participants
|
2 participants
n=2 Participants
|
11 participants
n=11 Participants
|
3 participants
n=3 Participants
|
—
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: The first participant contributed three lesions to each of the first three groups. The second participant likewise for the second three groups. The next two participants contributed three lesions each to each of the next two groups. The next two participants contributed likewise for the last two groups. PpIX positive areas were detected only in the last group.
The average fluorescence value for PpIX positive tumor areas in excised, sectioned tumors, as determined by fluorescence microscopy. PpIX signals were detected with excitation at 405 nm and emission with a 600 nm long pass filter. PpIX positive areas were determined to be those exhibiting fluorescence above background levels.
Outcome measures
| Measure |
Part 1 Levulan Injection Control Lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) injection and 24 hr incubation.
|
Part 1 Levulan Injection Treated Lesions 3 Hours
5-aminolevulinic acid uptake by treated lesions after Levulan injection and 3 hr incubation.
|
Part 1 Levulan Injection Treated Lesions 24 Hours
5-aminolevulinic acid uptake by treated lesions after Levulan injection and 24 hr incubation.
|
Part 1 Levulan Paint Control Lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 24 hr incubation.
|
Part 1 Levulan Paint Treated Lesions 3 Hours
5-aminolevulinic acid uptake by treated lesions after Levulan surface application and 3 hr incubation.
|
Part 1 Levulan Paint Treated Lesions 24 Hours
5-aminolevulinic acid uptake by treated lesions after Levulan surface application and 24 hr incubation.
|
Part 1 Levulan Painted Twice Control Lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice and 3 hr incubation.
|
Part 1 Levulan Painted Twice Treated Lesions
5-aminolevulinic acid uptake by treated lesions after Levulan surface application twice and 3 hr incubation.
|
Part 1 Levulan Painted Twice Control Lesions With Microneedling
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice, on lesions prepared with microneedling, and 24 hr incubation.
|
Part 1 Levulan Painted Twice Treated Lesions With Microneedling
n=10 PpIX positive areas
5-aminolevulinic acid uptake by treated lesions after Levulan surface application twice, on lesions prepared with microneedling, and 24 hr incubation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Photosensitizer Uptake and Conversion to Protoporphyrin IX
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
304 Densitometry units/micrometer squared
Standard Deviation 94
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Of the 14 enrolled in Part 2, 5 did not receive red light treatment per protocol. No subjects were enrolled in cohort 3 (200 J/cm\^2) due to marked pain in cohort 2. In the opinion of the clinical dermatologist, higher dose levels would likely not be tolerable, and it would be unethical to escalate the light dose further. It was decided that the MTD would be set at 100 J/cm\^2, and the highest dose level foregone.
MTD was determined by testing increasing doses up to 200 J/cm\^2 on dose escalation cohorts 1 to 3 with 3 to 6 participants each. MTD reflects the highest dose of red light that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants. DLT was defined as pain during irradiation requiring cessation of the light treatment, or any serious cutaneous adverse events.
Outcome measures
| Measure |
Part 1 Levulan Injection Control Lesions
n=9 Participants
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) injection and 24 hr incubation.
|
Part 1 Levulan Injection Treated Lesions 3 Hours
5-aminolevulinic acid uptake by treated lesions after Levulan injection and 3 hr incubation.
|
Part 1 Levulan Injection Treated Lesions 24 Hours
5-aminolevulinic acid uptake by treated lesions after Levulan injection and 24 hr incubation.
|
Part 1 Levulan Paint Control Lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 24 hr incubation.
|
Part 1 Levulan Paint Treated Lesions 3 Hours
5-aminolevulinic acid uptake by treated lesions after Levulan surface application and 3 hr incubation.
|
Part 1 Levulan Paint Treated Lesions 24 Hours
5-aminolevulinic acid uptake by treated lesions after Levulan surface application and 24 hr incubation.
|
Part 1 Levulan Painted Twice Control Lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice and 3 hr incubation.
|
Part 1 Levulan Painted Twice Treated Lesions
5-aminolevulinic acid uptake by treated lesions after Levulan surface application twice and 3 hr incubation.
|
Part 1 Levulan Painted Twice Control Lesions With Microneedling
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice, on lesions prepared with microneedling, and 24 hr incubation.
|
Part 1 Levulan Painted Twice Treated Lesions With Microneedling
5-aminolevulinic acid uptake by treated lesions after Levulan surface application twice, on lesions prepared with microneedling, and 24 hr incubation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Maximum Tolerated Dose (MTD) of 633 nm Red Light
|
100 joules/cm squared
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: The first participant contributed three lesions to each of the first three groups. The second participant contributed three lesions to each of the second three groups. Only the six groups in the first two arms are relevant to this outcome measure.
An optimal occlusion time may be apparent from the results of the three time points. If no optimal occlusion time is seen, any occlusion time from 3-24 hours may be chosen for part 2. This secondary outcome measure is not critical to continuing the study, but may be useful in guiding treatment protocols
Outcome measures
| Measure |
Part 1 Levulan Injection Control Lesions
n=3 lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) injection and 24 hr incubation.
|
Part 1 Levulan Injection Treated Lesions 3 Hours
n=3 lesions
5-aminolevulinic acid uptake by treated lesions after Levulan injection and 3 hr incubation.
|
Part 1 Levulan Injection Treated Lesions 24 Hours
n=3 lesions
5-aminolevulinic acid uptake by treated lesions after Levulan injection and 24 hr incubation.
|
Part 1 Levulan Paint Control Lesions
n=3 lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 24 hr incubation.
|
Part 1 Levulan Paint Treated Lesions 3 Hours
n=3 lesions
5-aminolevulinic acid uptake by treated lesions after Levulan surface application and 3 hr incubation.
|
Part 1 Levulan Paint Treated Lesions 24 Hours
n=3 lesions
5-aminolevulinic acid uptake by treated lesions after Levulan surface application and 24 hr incubation.
|
Part 1 Levulan Painted Twice Control Lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice and 3 hr incubation.
|
Part 1 Levulan Painted Twice Treated Lesions
5-aminolevulinic acid uptake by treated lesions after Levulan surface application twice and 3 hr incubation.
|
Part 1 Levulan Painted Twice Control Lesions With Microneedling
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice, on lesions prepared with microneedling, and 24 hr incubation.
|
Part 1 Levulan Painted Twice Treated Lesions With Microneedling
5-aminolevulinic acid uptake by treated lesions after Levulan surface application twice, on lesions prepared with microneedling, and 24 hr incubation.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Optimal Occlusion Time
|
NA hours
No optimal occlusion time was determined as no lesions showed PpIX fluorescence.
|
NA hours
No optimal occlusion time was determined as no lesions showed PpIX fluorescence.
|
NA hours
No optimal occlusion time was determined as no lesions showed PpIX fluorescence.
|
NA hours
No optimal occlusion time was determined as no lesions showed PpIX fluorescence.
|
NA hours
No optimal occlusion time was determined as no lesions showed PpIX fluorescence.
|
NA hours
No optimal occlusion time was determined as no lesions showed PpIX fluorescence.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Only 5 participants from Part 2 dose level 1 of the study had lesion sizes monitored during follow-up visits.
Average lesion growth rates observed in ALA-treated lesions compared to vehicle-treated lesions within the same subjects.
Outcome measures
| Measure |
Part 1 Levulan Injection Control Lesions
n=14 lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) injection and 24 hr incubation.
|
Part 1 Levulan Injection Treated Lesions 3 Hours
n=14 lesions
5-aminolevulinic acid uptake by treated lesions after Levulan injection and 3 hr incubation.
|
Part 1 Levulan Injection Treated Lesions 24 Hours
5-aminolevulinic acid uptake by treated lesions after Levulan injection and 24 hr incubation.
|
Part 1 Levulan Paint Control Lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 24 hr incubation.
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Part 1 Levulan Paint Treated Lesions 3 Hours
5-aminolevulinic acid uptake by treated lesions after Levulan surface application and 3 hr incubation.
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Part 1 Levulan Paint Treated Lesions 24 Hours
5-aminolevulinic acid uptake by treated lesions after Levulan surface application and 24 hr incubation.
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Part 1 Levulan Painted Twice Control Lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice and 3 hr incubation.
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Part 1 Levulan Painted Twice Treated Lesions
5-aminolevulinic acid uptake by treated lesions after Levulan surface application twice and 3 hr incubation.
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Part 1 Levulan Painted Twice Control Lesions With Microneedling
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice, on lesions prepared with microneedling, and 24 hr incubation.
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Part 1 Levulan Painted Twice Treated Lesions With Microneedling
5-aminolevulinic acid uptake by treated lesions after Levulan surface application twice, on lesions prepared with microneedling, and 24 hr incubation.
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Part 2: Efficacy - Lesion Area Growth Rate
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0.212 millimeter squared/day post-treatment
Standard Deviation 0.364
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0.081 millimeter squared/day post-treatment
Standard Deviation 0.176
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SECONDARY outcome
Timeframe: 1 yearPopulation: No cosmetic improvement data was collected.
Potential cosmetic improvement using subject satisfaction scale.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: No pain reduction data was collected.
Potential pain reduction, as measured by standard visual analog 1-10 scale.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: 48 hoursPopulation: Only 5 participants from Part 2 dose level 1 of the study had biopsies performed and lesions analyzed.
Average number of apoptotic cells per visual field among all TUNEL-evaluated lesion samples.
Outcome measures
| Measure |
Part 1 Levulan Injection Control Lesions
n=15 Lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) injection and 24 hr incubation.
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Part 1 Levulan Injection Treated Lesions 3 Hours
n=5 Lesions
5-aminolevulinic acid uptake by treated lesions after Levulan injection and 3 hr incubation.
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Part 1 Levulan Injection Treated Lesions 24 Hours
5-aminolevulinic acid uptake by treated lesions after Levulan injection and 24 hr incubation.
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Part 1 Levulan Paint Control Lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application and 24 hr incubation.
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Part 1 Levulan Paint Treated Lesions 3 Hours
5-aminolevulinic acid uptake by treated lesions after Levulan surface application and 3 hr incubation.
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Part 1 Levulan Paint Treated Lesions 24 Hours
5-aminolevulinic acid uptake by treated lesions after Levulan surface application and 24 hr incubation.
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Part 1 Levulan Painted Twice Control Lesions
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice and 3 hr incubation.
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Part 1 Levulan Painted Twice Treated Lesions
5-aminolevulinic acid uptake by treated lesions after Levulan surface application twice and 3 hr incubation.
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Part 1 Levulan Painted Twice Control Lesions With Microneedling
5-aminolevulinic acid uptake by control lesions after Levulan vehicle (placebo) surface application twice, on lesions prepared with microneedling, and 24 hr incubation.
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Part 1 Levulan Painted Twice Treated Lesions With Microneedling
5-aminolevulinic acid uptake by treated lesions after Levulan surface application twice, on lesions prepared with microneedling, and 24 hr incubation.
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TUNEL Assay.
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42.5 apoptotic cells/visual field
Standard Deviation 19.9
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1.1 apoptotic cells/visual field
Standard Deviation 1.4
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Adverse Events
Part 1 Levulan (5-aminolevulinic Acid) Uptake.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: Part 2 Dose Level 1 50 J/cm^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2 Dose Level 2 100 J/cm^2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 Levulan (5-aminolevulinic Acid) Uptake.
n=6 participants at risk
Tumors will be incubated with Levulan or vehicle under occlusion for 3 or 24 hrs. A minimum of three tumors per treatment or control group will be treated on the same subject. Tumors will then be excised in the normal manner. Tumors will be sectioned vertically and checked for PpIX using fluorescence microscopy.
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Experimental: Part 2 Dose Level 1 50 J/cm^2
n=11 participants at risk
Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1 - 50 J/cm\^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
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Part 2 Dose Level 2 100 J/cm^2
n=3 participants at risk
Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 2 - 100 J/cm\^2 633 nm red light to Levulan vehicle (placebo) treated control lesions or Levulan treated lesions and 24 hr incubation. Follow-ups on day 2 for punch biopsies, 14-28 days for evaluation of cutaneous adverse events, and every 3 months up to one year for lesion measurements.
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Skin and subcutaneous tissue disorders
Skin burning with PDT - resolved
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0.00%
0/6 • 3 weeks.
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9.1%
1/11 • Number of events 1 • 3 weeks.
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0.00%
0/3 • 3 weeks.
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Additional Information
Harry T. Whelan MD, Bleser Professor of Neurology
Medical College of Wisconsin
Phone: 414-266-7544
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place