Trial Outcomes & Findings for The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy (NCT NCT02594644)
NCT ID: NCT02594644
Last Updated: 2018-11-29
Results Overview
The primary endpoint will be the difference in the percentage of complete clearance of the actinic keratoses as an intraindividual comparison between the treatment groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Baseline, 2 Months
Results posted on
2018-11-29
Participant Flow
Participant milestones
| Measure |
10-minute Incubation With Microneedle Roller & Sham
10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
20-minute Incubation With Microneedle Roller
20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
10-minute Incubation With Microneedle Roller & Sham
n=16 Participants
10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
20-minute Incubation With Microneedle Roller & Sham
n=16 Participants
20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=32 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=16 Participants
|
10 Participants
n=16 Participants
|
15 Participants
n=32 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=16 Participants
|
6 Participants
n=16 Participants
|
17 Participants
n=32 Participants
|
|
Age, Continuous
|
65.4375 years
STANDARD_DEVIATION 9.858795 • n=16 Participants
|
62.75 years
STANDARD_DEVIATION 8.575158 • n=16 Participants
|
64.09 years
STANDARD_DEVIATION 9.19101 • n=32 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=16 Participants
|
5 Participants
n=16 Participants
|
10 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=16 Participants
|
11 Participants
n=16 Participants
|
22 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline, 2 MonthsThe primary endpoint will be the difference in the percentage of complete clearance of the actinic keratoses as an intraindividual comparison between the treatment groups.
Outcome measures
| Measure |
10-minute Incubation With Microneedle Roller
n=16 Participants
10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
20-minute Incubation With Microneedle Roller
n=16 Participants
20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
10-minute Incubation With Sham Microneedles
n=16 Participants
10-minute topical aminolevulinic acid incubation group. Binary randomization of subjects into treatment groups and secondary binary randomization for application of the microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
20-minute Incubation With Sham Microneedles
n=16 Participants
20-minute topical aminolevulinic acid incubation group. Binary randomization of subjects into treatment groups and secondary binary randomization for application of the microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
Pain_PDT: 10-minute Incubation With Microneedle Sham
10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
Pain_PDT: 10-minute Incubation With Microneedle Roller
10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
Pain_PDT: 20-minute Incubation With Microneedle Sham
20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
Pain_PDT: 20-minute Incubation With Microneedle Roller
20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
|---|---|---|---|---|---|---|---|---|
|
Difference in the Percentage of Complete Clearance of the Actinic Keratoses
|
43 Percentage of AK Clearance
Standard Error 13
|
76 Percentage of AK Clearance
Standard Error 3.9
|
38 Percentage of AK Clearance
Standard Error 8.1
|
58 Percentage of AK Clearance
Standard Error 5.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately Post-TreatmentThe secondary will be any pain associated with the microneedle pretreatment and with the application of the PDT using the 100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Outcome measures
| Measure |
10-minute Incubation With Microneedle Roller
n=16 Participants
10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
20-minute Incubation With Microneedle Roller
n=16 Participants
20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
10-minute Incubation With Sham Microneedles
n=16 Participants
10-minute topical aminolevulinic acid incubation group. Binary randomization of subjects into treatment groups and secondary binary randomization for application of the microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
20-minute Incubation With Sham Microneedles
n=16 Participants
20-minute topical aminolevulinic acid incubation group. Binary randomization of subjects into treatment groups and secondary binary randomization for application of the microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
Pain_PDT: 10-minute Incubation With Microneedle Sham
n=16 Participants
10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
Pain_PDT: 10-minute Incubation With Microneedle Roller
n=16 Participants
10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
Pain_PDT: 20-minute Incubation With Microneedle Sham
n=16 Participants
20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
Pain_PDT: 20-minute Incubation With Microneedle Roller
n=16 Participants
20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.
Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
|
|---|---|---|---|---|---|---|---|---|
|
Visual Analog Pain Scale
|
1.4 Millimeters
Standard Error .5
|
1.3 Millimeters
Standard Error .4
|
.3 Millimeters
Standard Error .2
|
.3 Millimeters
Standard Error .2
|
0.3 Millimeters
Standard Error 0.2
|
.5 Millimeters
Standard Error .2
|
0.4 Millimeters
Standard Error 0.1
|
.7 Millimeters
Standard Error .2
|
Adverse Events
10-minute Incubation With Microneedle Roller & Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
20-minute Incubation With Microneedle Roller & Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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