Treatment of actinic keratoses with sequential use of photodynamic therapy; and imiquimod 5% cream.

BACKGROUND: Field-directed therapies for actinic keratosis include photodynamic therapy and imiquimod. OBJECTIVES: The author designed a randomized, vehicle-controlled, split-face study to explore the safety and efficacy of photodynamic therapy followed by imiquimod. METHODS: The entire face of adults with > or =10 facial actinic keratoses were treated with photodynamic therapy with aminolevulinic acid 20% at baseline and at month 1. At month 2, imiquimod 5% cream was applied to one-half of the face and vehicle to the other half, 2-times-per-week for 16 weeks. Lesion counts were performed at baseline and months 1, 2, 3, 4, 6, and 12; and local skin reactions assessments at months 2, 3, 4, and 6. RESULTS: Of 25 participants enrolled, 24 completed the study. Baseline median lesions were 23.5 and 21.5 for the imiquimod- and vehicle-treated sides, respectively. At month 12, median lesion reductions was 89.9% versus 74.5% (P=.0023), respectively. No subject discontinued for an adverse event. Severe local skin reactions occurring in the most participants were erythema (17%) and flaking/scaling/dryness (13%). CONCLUSIONS: Photodynamic therapy followed by imiquimod was well tolerated and improved reduction of actinic keratoses.