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Abstract
Actinic keratoses (AKs) are a common precancerous condition and are said to account for 14% of visits to dermatologists in the US each year. Along with cryotherapy, topical treatments are a mainstay of therapy for these lesions. One of the potential benefits of topical therapy is less pain and irritation as compared to cryotherapy. Additionally, topical therapies have a perceived benefit of treating subclinical lesions along with clinically evident keratoses. We conducted a bilateral comparison study of the efficacy and tolerability of diclofenac 3% gel used for 90 days and 5% fluorouracil cream used for 28 days in thirty patients with AK of the face and scalp. The diclofenac gel and 5-fluorouracil cream each demonstrated substantial efficacy in the number of lesions cleared and the proportion of patients with significant lesion clearing. In most patients, diclofenac induced only mild signs of inflammation compared to 5-fluoruracil, despite a longer treatment period. A greater number of patients expressed significant satisfaction with diclofenac gel compared to the 5-fluorouracil cream.

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Introduction
Hyperplastic, epidermal premalignant lesions called actinic keratoses (AKs) are common in fair skinned individuals. These lesions are the result of overexposure to UV irradiation and, north of the equator, AKs occur in about 18% of the population. (1) This problem results in 47 million (6) office visits to dermatologists in the US each year. (2) Indeed, AKs represents one of the most common reasons for visiting a dermatologist. Since about 8% of metastatic squamous cell carcinomas (SCC) start as AKs, efficacious treatment that has a high compliance rate becomes a very sought after modality. (3)
Currently, several types of therapies for AKs are available. These include destructive methods such as cryotherapy, chemical peeling or laser resurfacing, and the more recently introduced photodynamic therapy, as well as topical treatments directed at atypical cell growth. (4) Topical treatments include 5-fluorouracil products, imiquimod, and diclofenac sodium 3% gel. The advantage of topical treatments is that they facilitate the eradication of subclinical, preinvasive lesions. This study was performed to compare the efficacy and tolerability profiles of 2 currently marketed therapies, diclofenac sodium 3% gel (Solaraze[R], Bradley Pharmaceuticals, Fairfield, NJ) (DFS) and 5% fluorouracil cream (Efudex[R], Valeant Pharmaceuticals, Costa Mesa, CA) (5-FU).
Materials and Methods
In this single center, bilateral, open-label, evaluator blinded study, DFS was compared to 5-FU in patients with at least 3 AKs on each side of the face and/or scalp with relative symmetry of the AK distribution. Thirty patients (23 males, 7 females) with at least 3 AKs on either side of the face and/or scalp were enrolled. Study exclusion criteria included pregnancy or lactation, patient’s unwillingness to use adequate birth control measures if appropriate, use of medications effective against AKs within 4 weeks prior to enrollment, photodynamic therapy within less than 1 month, treatment with another investigational device or drug within 1 month, systemic retinoid therapy within 6 months, or an allergy or sensitivity to any component of the study medications. A subject who had an untreated cutaneous malignancy within the treatment area was also excluded. The study was overseen by an intuitional review board; all patients gave written informed consent prior to any study-related procedures.
Enrolled patients applied DFS twice daily to a randomly selected side of the face and/or scalp for an initial 62 days. On this day, addition of twice daily application of 5-FU to the contralateral side of the face and/or scalp for the final 28 days was initiated. The patients also continued to treat the side of the face that had received DFS for the remaining 28 days. The patients thus received the recommended 90 days of therapy with DFS and 28 days of therapy with 5-FU.
Patients underwent evaluations by both a blinded and an unblinded evaluating dermatologist. Initially, patients were evaluated by both the blinded and unblinded investigator to ensure agreement on location and severity of AK lesions. Patients were then evaluated at days 30, 62, and 76 by the unblinded investigator to ensure compliance and assess to lerability. At day 90 (end of treatment) and day 120 (30 days post-treatment), the patients again were evaluated by the investigator that was blinded with respect to the study medication assignment.
AKs were graded as unchanged, partially improved, or resolved. Patients were evaluated for efficacy by determining the number and proportion of AK lesions that had resolved as well as through changes in their Global Improvement Score for each side of the face and/or scalp. Tolerability was assessed by evaluator grading of erythema, scaling, edema, and oozing/crusting. Patients were asked to grade the severity of pain and stinging as well as their degree of satisfaction with the treatment.