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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10-minute Incubation with Microneedle Roller & Sham | Experimental | 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. |
|
| 20-minute Incubation with Microneedle Roller & Sham | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedle Roller | Device | The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raja Sivamani, M.D. | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California-Davis, Department of Dermatology | Sacramento | California | 95816 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28514458 | Derived | Petukhova TA, Hassoun LA, Foolad N, Barath M, Sivamani RK. Effect of Expedited Microneedle-Assisted Photodynamic Therapy for Field Treatment of Actinic Keratoses: A Randomized Clinical Trial. JAMA Dermatol. 2017 Jul 1;153(7):637-643. doi: 10.1001/jamadermatol.2017.0849. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
In each group we initially enrolled 16 participants. In the 20 minute incubation group, we had 1 dropout which left us with 15 participants that finished.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | Percentage of AK Clearance | Baseline, 2 Months |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tatyana Petukhova MD | UC Davis Department of Dermatology | tpetukhova@ucdavis.edu |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| D000095743 | Blue Light |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Aminolevulinic Acid | Drug | Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA |
|
| Blue Light | Radiation | Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA |
|
| Immediately Post-Treatment |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | 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 |
| OG002 | 10-minute Incubation With Sham Microneedles | 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 |
| OG003 | 20-minute Incubation With Sham Microneedles | 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 |
|
|
| 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. | Posted | Mean | Standard Error | Millimeters | Immediately Post-Treatment |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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 | 0 | 16 | 0 | 16 | 0 | 16 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D055620 | Optical Phenomena |
| D011827 | Radiation |
| D011840 | Radiation, Nonionizing |