Conditions: Actinic Keratosis
Keywords: actinic keratosis microneedles photodynamic therapy levulan Aminolevulinic acid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 51
Healthy volunteers: yes

Brief summary:
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:

1. Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc.
2. Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Microneedle intervention 2: Aminolevulinic Acid intervention 3: Blue light
Intervention descriptions: intervention 1: 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. intervention 2: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA intervention 3: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)

Protocol document: