Long-term follow up of diclofenac sodium 3% in 2.5% hyaluronic acid gel for actinic keratosis: One-year evaluation

Objective: To evaluate the long-term effects of treatment with diclofenac sodium 3% in 2.5% hyaluronic acid gel on clinically diagnosed actinic keratosis lesions in well-defined skin areas. Design: A one-year extension of a Phase 4, single-arm, multicenter, open-label study was conducted. Patients in the original study received diclofenac sodium 3% gel twice daily for 90 days. The extension study consisted of a single evaluation approximately one year post-treatment. Setting: Five US centers. Participants: Patients who had completed the initial treatment phase with no further treatment for actinic keratosis in the designated treatment blocks. Measurements: The primary endpoint was the proportion of patients achieving 75-percent clearance of actinic keratosis lesions at one-year follow up based on percent change from baseline in target lesion number score or cumulative lesion number score. Secondary endpoints were the proportion of patients achieving 100-percent actinic keratosis lesion clearance and change in investigator's global improvement index scores. Results: Eighty-one percent of patients reported no additional treatment for actinic keratosis lesions for one year after completing treatment with diclofenac sodium 3% gel. The proportion of patients with 75-percent clearance after one year was 91 percent (95% CI, 84-99%) for target lesions and 70 percent (95% CI, 57-83%) for cumulative lesions. The proportion of patients with 100-percent clearance at one year was 79 percent (95% CI, 67-90%) for target lesions and 30 percent (95% CI, 17-43%) for cumulative lesions. Investigator's global improvement index severity scores showed that the majority (96%) of patients improved from baseline after one year. Conclusion: The efficacy of a single, 90-day course of diclofenac sodium 3% gel persisted in the majority of patients at one year.