Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Photosensitizing Agents

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 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.

The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.

Microneedle Roller

Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA

Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA

Blue Light

Raja Sivamani, M.D.

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.

The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

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.

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.

University of California, Davis

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

10-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

20-minute Incubation With Microneedle Roller & Sham

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

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.

Tatyana Petukhova MD

10-minute Incubation With Microneedle Roller

20-minute Incubation With Microneedle Roller

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

10-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

20-minute Incubation With Sham Microneedles

Difference in the Percentage of Complete Clearance of the Actinic Keratoses

Pain_microneedle: 10-minute Incubation With Microneedle Roller

Pain_microneedle: 20-minute Incubation With Microneedle Roller

Pain_microneedle: 10-minute Incubation With Microneedle Sham

Pain_microneedle: 20-minute Incubation With Microneedle 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

Pain_PDT: 10-minute Incubation With Microneedle Sham

Pain_PDT: 10-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

Spots Global Cancer Trial Database for The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

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