Safety and Efficacy of 0.5% Podofilox Gel in the Treatment of Anogenital Warts

Tyring, Stephen K.; Edwards, Libby; Cherry, Lisa; Ramsdell, William M.; Kotner, Steven; Greenberg, Mitchell; Vance, J. Corwin; Barnum, Gail; Dromgoole, Sydney H.; Killey, Frank P.; Toter, Tanya

doi:10.1001/archderm.134.1.33

Cited by 83 publications

(48 citation statements)

References 14 publications

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“…In the intent-to-treat analysis, after 8 weeks of therapy 62 of 167 patients (37.1%) treated with 0.5% podofilox gel had complete clearance of the treated areas compared with 2 of 86 patients (2.3%) who had clearing of warts with the vehicle gel (P Ͻ .001). 23 The 0.5% podofilox gel was well tolerated, with only 7 patients (3.2%) discontinuing study treatment because of drugrelated local reactions. 23 The marketed trade name product Condylox is a 0.5% podofilox gel.…”

Section: Wwwajogorgmentioning

confidence: 91%

“…23 The 0.5% podofilox gel was well tolerated, with only 7 patients (3.2%) discontinuing study treatment because of drugrelated local reactions. 23 The marketed trade name product Condylox is a 0.5% podofilox gel. Imiquimod is capable of inducing a variety of cytokines, including INF-␣, TNF-␣, as well as IL-1, -6, and -8.…”

Section: Wwwajogorgmentioning

confidence: 91%

“…Tyring et al 23 reported the outcomes of 326 patients with anogenital warts who were randomly assigned in a double-blind, vehicle-controlled, multicenter trial. In the intent-to-treat analysis, after 8 weeks of therapy 62 of 167 patients (37.1%) treated with 0.5% podofilox gel had complete clearance of the treated areas compared with 2 of 86 patients (2.3%) who had clearing of warts with the vehicle gel (P Ͻ .001).…”

Section: Wwwajogorgmentioning

confidence: 99%

See 2 more Smart Citations

Green tea catechins for treatment of external genital warts

Meltzer

Monk

Tewari

2009

American Journal of Obstetrics and Gynecology

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This review evaluates the antiviral, antioxidant, and immunostimulatory properties of green tea catechins. Two randomized trials evaluating the activity and efficacy of green tea catechins in the management of external genital warts are presented, and the reported side effects associated with this topical treatment modality are outlined. Finally, the mechanism of action, percent of wart clearance, time to clearance, and toxicity profile of green tea catechins are compared with those of podofilox and imiquimod, 2 other patient-administered topical agents approved for treatment of anogenital warts.

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Section: Wwwajogorgmentioning

confidence: 91%

Section: Wwwajogorgmentioning

confidence: 91%

Section: Wwwajogorgmentioning

confidence: 99%

See 1 more Smart Citation

Green tea catechins for treatment of external genital warts

Meltzer

Monk

Tewari

2009

American Journal of Obstetrics and Gynecology

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“…[60][61][62][63][64][65][66][67][68] No preparation of podophyllotoxin is licensed by the EMA or FDA for the treatment of AGWs, but UK marketing authorisations have been granted for podophyllotoxin 0.5% solution (Condyline ® , Takeda Pharmaceuticals Company Ltd; Warticon ® solution, Stiefel Laboratories Ltd) and 0.15% cream (Warticon ® cream, Stiefel Laboratories Ltd) preparations.…”

Section: Podophyllotoxinmentioning

confidence: 99%

“…Of the 137 full articles evaluated, 70 publications describing 60 studies (full publications [60][61][62][63][64][65][66][67][68] ) were relevant to the review. Citation details for conference abstracts related to full publications are provided only when additional information was available in the abstract.…”

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

Clinical effectiveness and cost-effectiveness of interventions for the treatment of anogenital warts: systematic review and economic evaluation

Thurgar¹,

Barton²,

Karner³

et al. 2016

Health Technol Assess

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BackgroundTypically occurring on the external genitalia, anogenital warts (AGWs) are benign epithelial skin lesions caused by human papillomavirus infection. AGWs are usually painless but can be unsightly and physically uncomfortable, and affected people might experience psychological distress. The evidence base on the clinical effectiveness and cost-effectiveness of treatments for AGWs is limited.ObjectivesTo systematically review the evidence on the clinical effectiveness of medical and surgical treatments for AGWs and to develop an economic model to estimate the cost-effectiveness of the treatments.Data sourcesElectronic databases (MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library databases and Web of Science) were searched from inception (or January 2000 for Web of Science) to September 2014. Bibliographies of relevant systematic reviews were hand-searched to identify potentially relevant studies. The World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov were searched for ongoing and planned studies.Review methodsA systematic review of the clinical effectiveness literature was carried out according to standard methods and a mixed-treatment comparison (MTC) undertaken. The model implemented for each outcome was that with the lowest deviance information criterion. A de novo economic model was developed to assess cost-effectiveness from the perspective of the UK NHS. The model structure was informed through a systematic review of the economic literature and in consultation with clinical experts. Effectiveness data were obtained from the MTC. Costs were obtained from the literature and standard UK sources.ResultsOf 4232 titles and abstracts screened for inclusion in the review of clinical effectiveness, 60 randomised controlled trials (RCTs) evaluating 19 interventions were included. Analysis by MTC indicated that ablative techniques were typically more effective than topical interventions at completely clearing AGWs at the end of treatment. Podophyllotoxin 0.5% solution (Condyline®, Takeda Pharmaceutical Company Ltd; Warticon®solution, Stiefel Laboratories Ltd) was found to be the most effective topical treatment evaluated. Networks for other outcomes included fewer treatments, which restrict conclusions on the comparative effectiveness of interventions. In total, 84 treatment strategies were assessed using the economic model. Podophyllotoxin 0.5% solution first line followed by carbon dioxide (CO2) laser therapy second line if AGWs did not clear was most likely to be considered a cost-effective use of resources at a willingness to pay of £20,000–30,000 per additional quality-adjusted life-year gained. The result was robust to most sensitivity analyses conducted.LimitationsLimited reporting in identified studies of baseline characteristics for the enrolled population generates uncertainty around the comparability of the study populations and therefore the generalisability of the results to clinical practice. Subgroup analyses were planned based on type, number and size of AGWs, all of which are factors thought to influence treatment effect. Lack of data on clinical effectiveness based on these characteristics precluded analysis of the differential effects of treatments in the subgroups of interest. Despite identification of 60 studies, most comparisons in the MTC are informed by only one RCT. Additionally, lack of head-to-head RCTs comparing key treatments, together with minimal reporting of results in some studies, precluded comprehensive analysis of all treatments for AGWs.ConclusionsThe results generated by the MTC are in agreement with consensus opinion that ablative techniques are clinically more effective at completely clearing AGWs after treatment. However, the evidence base informing the MTC is limited. A head-to-head RCT that evaluates the comparative effectiveness of interventions used in clinical practice would help to discern the potential advantages and disadvantages of the individual treatments. The results of the economic analysis suggest that podophyllotoxin 0.5% solution is likely to represent a cost-effective first-line treatment option. More expensive effective treatments, such as CO2laser therapy or surgery, may represent cost-effective second-line treatment options. No treatment and podophyllin are unlikely to be considered cost-effective treatment options. There is uncertainty around the cost-effectiveness of treatment with imiquimod, trichloroacetic acid and cryotherapy.Study registrationThis study is registered as PROSPERO CRD42013005457.FundingThe National Institute for Health Research Health Technology Assessment programme.

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New Treatments for Genital Warts Less Than Ideal

Fife¹

1998

JAMA

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Safety and Efficacy of 0.5% Podofilox Gel in the Treatment of Anogenital Warts

Cited by 83 publications

References 14 publications

Green tea catechins for treatment of external genital warts

Green tea catechins for treatment of external genital warts

Clinical effectiveness and cost-effectiveness of interventions for the treatment of anogenital warts: systematic review and economic evaluation

New Treatments for Genital Warts Less Than Ideal

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