Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 269
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 keratoses on the upper arms and hands

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Aminolevulinic Acid (ALA) intervention 2: Topical Solution Vehicle intervention 3: Blue Light Photodynamic Therapy Illuminator (BLU-U)
Intervention descriptions: intervention 1: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light intervention 2: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light intervention 3: 10 J/cm2 blue light delivered at 10mW/cm2

Protocol document: