Actinic Keratosis
Conditions
Keywords
actinic keratosis, microneedles, photodynamic therapy, levulan, Aminolevulinic acid
Brief summary
The global aim of this study is to investigate how microneedles can facilitate the penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses The specific aims are as follows: 1. Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc. 2. Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.
Interventions
DEVICEMicroneedle
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.
DRUGAminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
RADIATIONBlue light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects who are 18 and older 2. Subjects who have at least 3 actinic keratoses on each side of the forehead 3. Subjects who signed an IRB approved informed consent
Exclusion criteria
1. Subjects who smoke 2. Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition. 3. Subjects who received a diagnosis of skin cancer on the face in past year 4. Subjects who received field treatment for actinic keratoses to the face in the past 60 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Actinic Keratoses Reduction Percent | one month after treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 17 |
| 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) | 17 |
| 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) | 17 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | 60 Minute Microneedle Pretreatment Incubation | Total | 20 Minute Microneedle Pretreatment Incubation | 40 Minute Microneedle Pretreatment Incubation |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 30 Participants | 13 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 21 Participants | 4 Participants | 8 Participants |
| Age, Continuous | 66.2 years STANDARD_DEVIATION 10.3 | 67.7 years STANDARD_DEVIATION 9 | 70.1 years STANDARD_DEVIATION 6.4 | 66.9 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 17 participants | 51 participants | 17 participants | 17 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 13 Participants | 43 Participants | 14 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 0 / 17 |
Outcome results
Primary
Actinic Keratoses Reduction Percent
Time frame: one month after treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 20 Minute Microneedle Pretreatment Incubation | Actinic Keratoses Reduction Percent | Microneedle Pretreatment | 71.4 percentage | Standard Deviation 22.6 |
| 20 Minute Microneedle Pretreatment Incubation | Actinic Keratoses Reduction Percent | Control | 68.3 percentage | Standard Deviation 13 |
| 40 Minute Microneedle Pretreatment Incubation | Actinic Keratoses Reduction Percent | Microneedle Pretreatment | 80.2 percentage | Standard Deviation 18.7 |
| 40 Minute Microneedle Pretreatment Incubation | Actinic Keratoses Reduction Percent | Control | 80.1 percentage | Standard Deviation 18.1 |
| 60 Minute Microneedle Pretreatment Incubation | Actinic Keratoses Reduction Percent | Microneedle Pretreatment | 72.5 percentage | Standard Deviation 22.8 |
| 60 Minute Microneedle Pretreatment Incubation | Actinic Keratoses Reduction Percent | Control | 73.6 percentage | Standard Deviation 28.3 |