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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 minutes incubation - with pretreatment | Experimental |
| |
| 40 minutes incubation - with pretreatment | Experimental |
| |
| 60 minutes incubation - with pretreatment | Experimental |
| |
| 60 minutes incubation - no pretreatment | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedle | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Actinic Keratoses Reduction Percent | one month after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raja K Sivamani, MD | UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis, Dermatology | Sacramento | California | 95864 | United States |
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| Label | URL |
|---|---|
| University of California-Davis Department of Dermatology Clinical Research | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| FG002 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| 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 | Actinic Keratoses Reduction Percent | Posted | Mean | Standard Deviation | percentage | one month after treatment |
|
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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 | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raja Sivamani | UC Davis | 9167035145 | rksivamani@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) |
|
| BG001 | 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) |
| BG002 | 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) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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) |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | 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) | 0 | 17 | 0 | 17 |
| EG002 | 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) | 0 | 17 | 0 | 17 |
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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 |