Comparative study of actinic keratosis treatment with 3% diclofenac sodium and 5% 5-fluorouracil

Abstract

BACKGROUND Actinic keratosis is a frequent lesion which occurs in sunlight exposed areas. Diclofenac sodium and 5-Fluorouracil are effective, non-invasive and easy-to-apply topical treatment options. OBJECTIVES To assess and compare the effectiveness of 3% diclofenac sodium associated with 2.5% hyaluronic acid and of 5% 5-Fluorouracil for the treatment of actinic keratosis, as well as the patient's degree of satisfaction and tolerability. METHODS28 patients with a clinical diagnosis of actinic keratosis were randomized to receive diclofenac sodium or 5-Fluorouracil and were clinically assessed before and after treatment as well as 8 weeks after the end of treatment. Modified versions of the Investigator and Patient Global Improvement Scores were used. RESULTS The average number of lesions in the diclofenac sodium group before and after treatment was 13.6 and 6.6 (p<0,001), respectively, while it was 17.4 and 3.15 (p<0.001) in the 5-Fluorouracil group. There was a significant reduction in the number of lesions in the 5-Fluorouracil group in relation to the diclofenac sodium group (p<0.001). To the non-blinded physician, there was a higher satisfactory therapeutic response in the 5-Fluorouracil group (p<0.001); to the blinded physician, there was a higher satisfactory response in this same group, although not statistically significant (p=0.09). There was a high degree of satisfaction in both groups (73% in the diclofenac sodium group and 77% in the 5-Fluorouracil group; p=0.827). Regarding adverse effects, the diclofenac sodium group presented a higher degree of satisfaction (93.3% vs 38.4%; p=0.008). Erythema, edema, crusts and itching were significantly higher in the 5-Fluorouracil group. CONCLUSIONWe concluded that 5-Fluorouracil was more effective; however, it showed lower tolerability than diclofenac sodium.

Patient satisfaction and reported outcomes on the management of actinic keratosis

“…Patient satisfaction with lesion clearance was assessed using the Patient Global Improvement Score (unchanged, >50% of lesions were healed, and all lesions were healed). Results show that 54% of patients treated with 5-FU reported all lesions to be healed in comparison with 20% of patients treated with DFS 26. Despite the fact that patients treated with 5-FU experienced a significantly greater reduction in the number of lesions, DFS was better tolerated 26.…”

“…As per patient testimony, 73% of those treated with DFS and 77% of those treated with 5-FU were highly satisfied, revealing no significant difference between the groups 26. However, patients treated with DFS did report significantly higher satisfaction regarding adverse events (93.3% versus 38.4%, p = 0.008), since those treated with 5-FU observed more instances of erythema, edema, crusts, and itching 26. Patient satisfaction with lesion clearance was assessed using the Patient Global Improvement Score (unchanged, >50% of lesions were healed, and all lesions were healed).…”

“…Patients either applied 3% DFS gel twice daily for 12 weeks or 5% 5-FU cream twice daily for 4 weeks. As per patient testimony, 73% of those treated with DFS and 77% of those treated with 5-FU were highly satisfied, revealing no significant difference between the groups 26. However, patients treated with DFS did report significantly higher satisfaction regarding adverse events (93.3% versus 38.4%, p = 0.008), since those treated with 5-FU observed more instances of erythema, edema, crusts, and itching 26.…”

“…Although its mechanism of action is not entirely understood, it decreases arachidonic acid metabolite formation, which would normally inhibit apoptosis and increase angiogenesis 27,28. In a randomized, parallel-group clinical trial with 28 patients of both genders with at least five AKs on the face, scalp, or back of the hands, patient satisfaction for the treatment with 5% 5-FU and 3% DFS was reported in terms of satisfaction with adverse effects and lesion clearance 26. Patients either applied 3% DFS gel twice daily for 12 weeks or 5% 5-FU cream twice daily for 4 weeks.…”

Real-world approach to actinic keratosis management: practical treatment algorithm for office-based dermatology

“…As for imiquimod 5%, rare systemic reactions may occur during treatment with imiquimod 3.75% (72). shown that 5% 5-fluorouracil is less well tolerated than other AK treatments such as diclofenac sodium 3% and photodynamic therapy (77,78,80). Exposure to sunlight during 5% 5-fluorouracil treatment may increase the intensity of skin reactions (60).…”