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. (J Clin Aesthetic Dermatol. 2009;2(7):20-25.).