Efficacy and Safety of Phoenix dactylifera L. Leaf Extract (WartOver®) in the Treatment of Cutaneous Warts: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Background. Cutaneous warts are caused by the human papillomavirus that can affect a patient’s quality of life. Current treatments have high cost, low efficacy, adverse effects, and recurrence. Therefore, novel therapeutic approaches are needed. Complementary and Alternative Medicines (CAMs) are gaining popularity as a therapeutic approach. Phoenix dactylifera L. (date palm) is used in folk medicine to treat warts. Antiviral effects of P. dactylifera L. have been demonstrated due to its polyphenolic compounds, especially gallic acid and tannins in various studies. So, this trial evaluates the efficacy and safety of P. dactylifera L. leaf extract (formulated as WartOver®) as a novel treatment for cutaneous warts. Study Design. Based on the results of our previously published pilot clinical trial and the CONSORT guideline, this randomized, double-blind, and placebo-controlled study was performed on 70 eligible patients divided into intervention and placebo groups (N = 35/per group). Every 2 weeks, patients were examined to assess the rate of complete clearance, duration of treatment, patient satisfaction (measured using a Likert scale), and occurrence of any adverse effects and recurrence in a maximum of 12 weeks of treatment and at the 6-month follow-up. Results. Based on the intention-to-treat (ITT) analysis approach, complete clearance was achieved in 24 patients in the intervention group (68.57%; confidence interval 95% = 0.51–0.81), which was significantly higher than that in the placebo group (8.57%; CI 95% = 0.02–0.23, p<0.0001). The time to complete clearance was 7.6 weeks (mean ± SD: 53.30 ± 17.17 days). The treatment was very satisfactory (Likert score of 4.24 ± 1.15 (mean ± SD)) with no recurrence or adverse effects. Conclusion. WartOver® is a novel efficacious treatment for cutaneous warts with minimal risk for adverse events or recurrence. Due to the rising popularity of CAM approaches in medicine, including herbal medicines, WartOver® can be a valuable choice for clinicians against cutaneous warts. This trial is registered with IRCT20200509047352N2.