A Single-Arm, Open-Label Efficacy and Tolerability Study of Diclofenac Sodium 3% Gel for the Treatment of Actinic Keratosis of the Upper and Lower LipChristopher Nelson MD, James Spencer MD, Christopher Nelson Jr MD

Objectives and Methods: This study is an evaluation of patients diagnosed with actinic keratosis (AK) lesions of the upper and lower lip (both cutaneous and mucosal surfaces), with at least one lesion on the vermilion (mucosal) lip. Patients were treated twice daily with a topical application of diclofenac sodium 3% gel (Solaraze® Gel, Doak Dermatologics) for a period of 90 days with a follow-up assessment at 30 days post-treatment. The presence or absence of target and new lesions was assessed and quantified at the initial baseline visit and at each follow-up visit. An investigator global improvement index score assessment and an evaluation of tolerability was also performed at each follow-up visit. Conclusion: The application of diclofenac sodium 3% gel provides an effective approach for the treatment of AK of the lip. The cure rate reported in this study for AK of the lip was similar to that of diclofenac sodium 3% gel for AK on skin elsewhere on the body, and has a low incidence of irritation and other adverse reactions, as well as a high rate of patient satisfaction. The unique safety and tolerability profile of diclofenac sodium 3% gel would appear to lend itself well to treatment of the mucosal lip and vermilion, particularly when treatment decisions involve cosmetic appearance during and subsequent to therapy.