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Abstract
A clearance rate of all occurrences [greater than or equal to]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[TM]).
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 [cm.sup.2]) 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.

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Of the 76 patients who entered the study, 67 (88%) patients completed the study. At Day 90 of treatment, 78% of patients had [greater than or equal to]75% AK lesion clearance based on the target lesion number score (TLNS). Improving to 85% of patients demonstrating [greater than or equal to]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.
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Introduction
Actinic keratosis, or solar keratosis, is a pre-cancerous skin condition caused by excessive, prolonged exposure to ultraviolet light (1). The clinical features of AK lesions include rough, scaly patches, “bumps” on the skin, mottled skin, and cutaneous horns (2). These alterations in cell growth and differentiation can set the stage for evolution of AK lesions into invasive squamous cell carcinoma (SCC). In epidemiologic and histopathologic studies, AK lesions are the precursors of at least 60% of squamous cell cancers (3,4). As it is currently impossible to predict which lesions will progress to invasive SCCs, early and effective treatment is essential in reducing the risk of developing skin cancer in the longer term (5). SCC may account for up to 34% of deaths from skin cancer among adults to 84 years of age, and 56% of deaths among persons 85 years and older (6). Additionally, the morbidity and cost associated with SCC therapy is essential (7).
Destruction of AK lesions is the most commonly performed outpatient dermatological procedure in the United States. A National Ambulatory Medical Care Survey from 1993 and 1994 estimated that there were 3.7 million office visits and 5.2 million procedures for AK (more than 3 times the total office visits for squamous cell cancer, basal cell cancer, and melanoma combined) (8). The actual occurrence of AK lesions is likely to be much higher, as only a small proportion of individuals with AK lesions seek or receive treatment (9). The lesions of AK are most likely to appear in individuals over the age of 40, but in geographic areas with year-round high-intensity sunlight AK lesions are now found in persons as young as the teens and 20’s. Due to the link between exposure to sunlight and the later development of actinic keratosis, people who have spent significant periods of their life outdoors appear to be at highest risk.
Treatment for AK lesions has traditionally involved painful procedures including cryosurgery, surgical excision and biopsy (for lesions suspected of being cancerous), and topical chemotherapy. As a first-in-class therapy, 3.0% diclofenac sodium gel provides an alternative topical treatment for AK lesions.
Randomized, double-blind, vehicle-controlled clinical trials have demonstrated the effectiveness of 3.0% diclofenac sodium gel in the clearance of 100% of AK lesions when applied for 60-90 days (10,11). These trials also demonstrated the tolerability of 3.0% diclofenac sodium gel, which has a low systemic absorption profile. This five-center, single-arm, open-label study was conducted to assess the efficacy and tolerability of 3.0% diclofenac sodium gel in the treatment of AK.
Methods and Patients
Study Design and Clinical Assessments
This was a multicenter, single-arm, open-label study. Patients were eligible for enrollment into the study at five centers in the USA if they met the inclusion and exclusion criteria, and the patient and physician agreed that treatment with 3.0% diclofenac sodium gel was an appropriate form of therapy. The treatment period was 90 days with monthly clinic visits (Days 30, 60, and 90), and a follow-up visit 30 days post-treatment (Day 120). Written informed consent was obtained from each patient prior to screening procedures.