Ingenol mebutate gel .05% in the treatment of anogenital warts: a prospective controlled trial comparing it with topical podophyllin solution 25.

BACKGROUND: Anogenital warts (AGW) are a common therapeutic challenge. All therapies are associated with burning, pain and frustrating high rate of recurrence. The search for a new alternative continues. Recently a diterpene ester extracted from the Euphorbia Peplus plant (Ingenol mebutate (IM)) has been shown to possess activity against anogenital warts. OBJECTIVE: To compare and evaluate the therapeutic efficacy and safety of topical .05% ingenol gel with another herbal extract medication ( topical 25% podophyllin solution) in treatment of AGWs. METHODS: This was a comparative single blinded non-randomized, 2-arm trial of Ingenol .05% gel versus podophyllin solution 25% administered up to 6 times to patients with AGWs. To evaluate the therapeutic efficacy, the complete clearance rate and recurrence rate were assessed one week and 12 weeks after last treatment respectively. Safety was assessed by occurrence and severity of pain and local skin reaction (LSR). RESULTS: Out of 31 and 36 patients in IM group and podophyllin group who completed the study, initial complete resolution was observed in 20 (64.5%) and 14(38.9%) patients respectively P=0.03. The initial clearance was faster in the IM group (2.00+/-0.91 weeks) compared with podophyllin group (4.21+/-1.05 weeks), P= 0.00. After 3 months, recurrence was seen in 13/20 (65.0%) patients in IM group and 6/14 (42.8%) in podophyllin group, P=0.20.The number of patients with complete resolution after 3 months was not different between two groups ( 7/31 in IM group and 8/36 in podophyllin group, P=0.9). The mean+/-SD severity score for LSR and pain in IM group was 6.65+/-1.76 and 6.13+/-2.57 respectively, which was significantly higher than their scores (3.39+/-1.57 and 2.58+/-1.38) in podophyllin group P=0.00. CONCLUSION: IM .05% gel is effective as podophyllin 25% solution in treating AGWs with further benefit of being much more rapid. However, high recurrence rate, sever pain and local skin reaction limit its use.