Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 137
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.

Detailed description:

Arms:
arm 1: ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. arm 2: Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. arm 3: ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. arm 4: Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. arm 5: ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. arm 6: Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. arm 7: ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. arm 8: Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. arm 9: Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. arm 10: Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.

Interventions: intervention 1: ALA intervention 2: Topical Solution Vehicle intervention 3: IBL 10 mW intervention 4: Microneedle lesion preparation intervention 5: IBL 20 mW
Intervention descriptions: intervention 1: 20% ALA applied to face prior to light treatment intervention 2: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment intervention 3: 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds intervention 4: Microneedling of all visible/palpable AK lesions prior to solution application. intervention 5: 10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds

Protocol document: