Conditions: Keratosis, Actinic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: no

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.

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Microneedle Roller intervention 2: Aminolevulinic Acid intervention 3: Blue Light
Intervention descriptions: intervention 1: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length. intervention 2: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA intervention 3: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA

Protocol document: