Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 166
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 (AK) on the face, following treatment with liquid nitrogen cryotherapy.

Detailed description:

Arms:
arm 1: Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments arm 2: Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. arm 3: Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments

Interventions: intervention 1: Aminolevulinic Acid intervention 2: Topical Solution Vehicle intervention 3: BLU-U intervention 4: Cryotherapy
Intervention descriptions: intervention 1: 20% ALA applied to face for one hour prior to 10 J/cm2 blue light intervention 2: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light intervention 3: 10 J/cm2 blue light delivered at 10 mW/cm2 intervention 4: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.

Protocol document: