Randomised controlled trial of 1% and 5% 5-fluorouracil creams compared with 90% trichloroacetic acid solution for anogenital wart treatment

Abstract

<jats:p> To evaluate the efficacy and safety of 1% and 5% 5-fluorouracil (5-FU) creams compared with 90% trichloroacetic acid (TCA) for the treatment of anogenital warts. we conducted a randomised controlled study in 72 subjects allocated to three groups: 1% 5-FU, 90% TCA and 5% 5-FU; 90% TCA was administered once a week, whereas 5-FU cream was applied three times a week. Response to therapy and side-effects were evaluated weekly for seven weeks. Evaluation at week 7 demonstrated that there was no significant difference in the efficacy between 1% 5-FU cream and 90% TCA ( p = 0.763) or between 5% 5-FU cream and 90% TCA ( p = 0.274). Subjective side-effects with 1% 5-FU were significantly milder than 90% TCA; however, significantly milder objective side-effects were observed only at weeks 2, 6 and 7. The subjective side-effects with 5% 5-FU were also significantly milder than 90% TCA; however, significantly milder objective side-effects were observed only at week 2. 5-FU may become an alternative topical therapy as it offers the benefit of self-application; furthermore, a concentration of 1% 5-FU cream is recommended due to milder side-effects. </jats:p>

5‐Fluorouracil 0.5%/salicylic acid 10% solution in the treatment of ano‐genital warts

“…In our series, at 3 months from the beginning of the therapy, complete clearance of the lesions was achieved in 53% of patients (Figures 1 and 2) and partial clearance in 35%, confirming the efficacy of 5‐FU/SAsol in the treatment of AGWs found in a previous study 5 . Other authors, evaluating the effectiveness of 5‐FU at higher concentrations (1% and 5%), found higher cure rates (respectively, 67% and 46%) after only 7 weeks 6 …”

“…A simplified algorithm suggests that patients with 1–5 warts should firstly be treated with ablative techniques (cryotherapy, diathermocoagulation, carbon dioxide lasers, surgery) while patients with >5 warts should use immunotherapies (imiquimod or sinecatechins cream) 2 . Other therapeutic options are destructive (salicylic acid, nitrizinc‐complex, potassium hydroxide solutions), virucidal (topical/intralesional cidofovir, intralesional interferon‐α, podophyllotoxin cream), immunotherapeutics (candida antigen injection, Bacillus Calmette‐Guérin injection, contact allergen immunotherapy) and antimitotic (podophyllotoxin cream, 5‐fluorouracil cream) 2–6 …”

“…The patient obtained a complete resolution of the lesions cutaneous adverse events between 5-FU and other treatments. 5,6,11 A Cochrane review found that 5-FU was superior to placebo in achieving wart clearance but, since the evidences provided by the studies were weak, 5-FU could not be recommended for first-line use, but when other treatments have failed. 12 In our series, at 3 months from the beginning of the therapy, complete clearance of the lesions was achieved in 53% of patients (Figures 1 and 2) and partial clearance in 35%, confirming the efficacy of 5-FU/SAsol in the treatment of AGWs found in a previous study.…”

“…However, it has been demonstrated that the 5‐FU/SAsol can be applied safely since less than 0.1% of the dose applied was absorbed through the skin 10 and there are no significant differences in terms of cutaneous adverse events between 5‐FU and other treatments 5,6,11 . A Cochrane review found that 5‐FU was superior to placebo in achieving wart clearance but, since the evidences provided by the studies were weak, 5‐FU could not be recommended for first‐line use, but when other treatments have failed 12 …”

“…Moreover, there is no therapy that can directly eradicates HPV 2–6 . Numerous studies on different therapeutic modalities are available; however, data on the efficacy of 5‐fluouracil/salicylic acid solution in the treatment of AGWs are scarse 5,6 …”