Phase IV, open-label assessment of the treatment of actinic keratosis with 3.0% diclofenac sodium topical gel (Solaraze).

A clearance rate of all occurrences > or = 75% for actinic keratoses (AK) lesions is an accepted efficacy endpoint for topical agents. This efficacy endpoint has not been assessed for 3.0% diclofenac sodium gel (Solaraze). We evaluated the efficacy and tolerability of 3.0% diclofenac sodium gel in the treatment of AK for a treatment period of 90 days and a 30-day follow-up period. This is a multicenter, single-arm, open-label study in patients diagnosed with five or more AK lesions contained in 1 to 3 blocks (5 cm2) on the forehead, central face, or scalp. Patients were treated twice daily with a topical application of 3.0% diclofenac sodium gel for a period of 90 days with a follow-up assessment at 30 days post-treatment. The presence or absence of target lesions and new lesions was assessed at each visit a long with a global improvement index score. Of the 76 patients who entered the study, 67 (88%) patients completed the study. At Day 90 of treatment, 78% of patients had > or = 75% AK lesion clearance based on the target lesion number score (TLNS). Improving to 85% of patients demonstrating > or = 75% AK lesion clearance at Day 120 (follow-up). Improvement was also demonstrated by 100% AK lesion clearance based on the TLNS clearance (Day 90 of treatment: 41%; Day 120 [follow-up]: 58%). Similar improvements were shown in cumulative lesion number score (CLNS), which included new as well as targeted AK lesions within the designated treatment areas, at Day 90 and Day 120 (follow-up). Investigators' assessment based on Investigator Global Improvement Index (IGII) confirmed the efficacy of 3.0% diclofenac gel in the clearance of AK lesions. A total of 39 patients (51%) experienced at least 1 adverse event considered to be related to 3.0% diclofenac sodium gel during the study. Dry skin and rash at the application site were most common reported adverse events, and most of these adverse events were mild or moderate in severity. The topical application of 3.0% diclofenac sodium gel provides a safe and effective approach for the treatment of AK.