Trial Outcomes & Findings for The Use of Microneedles in Photodynamic Therapy (NCT NCT01812837)
NCT ID: NCT01812837
Last Updated: 2017-06-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
one month after treatment
Results posted on
2017-06-15
Participant Flow
Participant milestones
| Measure |
20 Minute Microneedle Pretreatment Incubation
20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
|
40 Minute Microneedle Pretreatment Incubation
40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
|
60 Minute Microneedle Pretreatment Incubation
60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
17
|
|
Overall Study
COMPLETED
|
15
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
20 Minute Microneedle Pretreatment Incubation
20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
|
40 Minute Microneedle Pretreatment Incubation
40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
|
60 Minute Microneedle Pretreatment Incubation
60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
The Use of Microneedles in Photodynamic Therapy
Baseline characteristics by cohort
| Measure |
20 Minute Microneedle Pretreatment Incubation
n=17 Participants
20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
|
40 Minute Microneedle Pretreatment Incubation
n=17 Participants
40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
|
60 Minute Microneedle Pretreatment Incubation
n=17 Participants
60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Age, Continuous
|
70.1 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
66.2 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
17 participants
n=5 Participants
|
51 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: one month after treatmentOutcome measures
| Measure |
20 Minute Microneedle Pretreatment Incubation
n=15 Participants
20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
|
40 Minute Microneedle Pretreatment Incubation
n=16 Participants
40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
|
60 Minute Microneedle Pretreatment Incubation
n=17 Participants
60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)
Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
|
|---|---|---|---|
|
Actinic Keratoses Reduction Percent
Microneedle Pretreatment
|
71.4 percentage
Standard Deviation 22.6
|
80.2 percentage
Standard Deviation 18.7
|
72.5 percentage
Standard Deviation 22.8
|
|
Actinic Keratoses Reduction Percent
Control
|
68.3 percentage
Standard Deviation 13.0
|
80.1 percentage
Standard Deviation 18.1
|
73.6 percentage
Standard Deviation 28.3
|
Adverse Events
20 Minute Microneedle Pretreatment Incubation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
40 Minute Microneedle Pretreatment Incubation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
60 Minute Microneedle Pretreatment Incubation
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