Conditions: Actinic Keratosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 235
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.

Detailed description:

Arms:
arm 1: Broad Area ALA 1-hour incubation arm 2: Broad Area ALA 2-hour incubation arm 3: Broad Area ALA 3-hour incubation arm 4: Spot ALA 2-hour incubation arm 5: VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.

Interventions: intervention 1: Broad Area ALA 1-hour incubation intervention 2: Broad Area ALA 2 hour incubation intervention 3: broad area ALA 3-hour incubation intervention 4: Spot ALA 2 hour incubation intervention 5: Vehicle PDT intervention 6: Blue Light Treatment
Intervention descriptions: intervention 1: 20% ALA, broad area, 1 hour incubation intervention 2: 20% ALA broad area 2-hour incubation intervention 3: 20% ALA broad area 3 hour incubation intervention 4: 20% ALA spot 2 hour incubation intervention 5: Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group. intervention 6: 10 J/cm2 blue light delivered at 10 mW/cm2

Protocol document: