Keratosis, Actinic
Conditions
Brief summary
The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.
Detailed description
The current standard of care of photodynamic therapy to treat actinic keratoses includes pre-treatment of the area with topical aminolevulinic acid for 1 hour, followed by treatment with blue light. In a previous study, the investigators showed pretreatment of microneedles enhance penetration of topical aminolevulinic acid as compared to the control group. The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.
Interventions
DEVICEMicroneedle Roller
The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.
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
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age and older * Subjects has actinic keratoses and qualifies for photodynamic therapy * Do not meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the Percentage of Complete Clearance of the Actinic Keratoses | Baseline, 2 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Pain Scale | Immediately Post-Treatment | The 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| 20-minute Incubation With Microneedle Roller & 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 | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | 10-minute Incubation With Microneedle Roller & Sham | 20-minute Incubation With Microneedle Roller & Sham | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 6 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 10 Participants | 15 Participants |
| Age, Continuous | 65.4375 years STANDARD_DEVIATION 9.858795 | 62.75 years STANDARD_DEVIATION 8.575158 | 64.09 years STANDARD_DEVIATION 9.19101 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
Difference in the Percentage of Complete Clearance of the Actinic Keratoses
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.
Time frame: Baseline, 2 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10-minute Incubation With Microneedle Roller | Difference in the Percentage of Complete Clearance of the Actinic Keratoses | 43 Percentage of AK Clearance | Standard Error 13 |
| 20-minute Incubation With Microneedle Roller | Difference in the Percentage of Complete Clearance of the Actinic Keratoses | 76 Percentage of AK Clearance | Standard Error 3.9 |
| 10-minute Incubation With Sham Microneedles | Difference in the Percentage of Complete Clearance of the Actinic Keratoses | 38 Percentage of AK Clearance | Standard Error 8.1 |
| 20-minute Incubation With Sham Microneedles | Difference in the Percentage of Complete Clearance of the Actinic Keratoses | 58 Percentage of AK Clearance | Standard Error 5.7 |
Secondary
Visual Analog Pain Scale
The 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.
Time frame: Immediately Post-Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10-minute Incubation With Microneedle Roller | Visual Analog Pain Scale | 1.4 Millimeters | Standard Error 0.5 |
| 20-minute Incubation With Microneedle Roller | Visual Analog Pain Scale | 1.3 Millimeters | Standard Error 0.4 |
| 10-minute Incubation With Sham Microneedles | Visual Analog Pain Scale | .3 Millimeters | Standard Error 0.2 |
| 20-minute Incubation With Sham Microneedles | Visual Analog Pain Scale | .3 Millimeters | Standard Error 0.2 |
| Pain_PDT: 10-minute Incubation With Microneedle Sham | Visual Analog Pain Scale | 0.3 Millimeters | Standard Error 0.2 |
| Pain_PDT: 10-minute Incubation With Microneedle Roller | Visual Analog Pain Scale | .5 Millimeters | Standard Error 0.2 |
| Pain_PDT: 20-minute Incubation With Microneedle Sham | Visual Analog Pain Scale | 0.4 Millimeters | Standard Error 0.1 |
| Pain_PDT: 20-minute Incubation With Microneedle Roller | Visual Analog Pain Scale | .7 Millimeters | Standard Error 0.2 |