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Condylox

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Condylox Gel

CLINICAL PHARMACOLOGY

Mechanism of Action

Treatment of anogenital warts with podofilox results in necrosis of visible wart tissue. The exact mechanism of action is unknown.

Pharmacokinetics

In systemic absorption studies in 52 patients, topical application of 0.05 ml_ of an ethanolic solution containing 0.5% podofilox to external genitalia did not result in detectable serum levels. Applications of 0.1 to 1.5 ml_ resulted in peak serum levels of 1 to 17 ng/mL one to two hours after application. The elimination half-life ranged from 1.0 to 4.5 hours. The drug was not found to accumulate after multiple treatments1.

Clinical Studies

In the first multicenter clinical study in 326 patients with anogenital warts, Condylox Gel (podofilox gel) 0.5% and its vehicle were applied in a double-blind fashion to comparable patient groups. Of the 260 patients with efficacy data, 176 were treated with Condylox Gel (podofilox gel) 0.5%. Patients applied Condylox Gel (podofilox gel) 0.5% twice daily for three consecutive days followed by a 4 day "rest" period.

At the end of 4 weeks, 38.4% of the patients had complete clearing of the wart tissue when treated with Condylox Gel (podofilox gel) 0.5%.

In the second multicenter clinical trial in 108 evaluable patients with anogenital warts, Condylox (podofilox) Topical Solution 0.5% was compared with Condylox Gel (podofilox gel) 0.5% for efficacy. As in the first clinical trial, patients applied Condylox Gel (podofilox gel) 0.5% twice daily for three consecutive days followed by a four day "rest" period.

Similar clearance rates were observed. At the end of 4 weeks, 25.6% of the patients had complete clearing of the wart tissue when treated with Condylox Gel (podofilox gel) 0.5%.

REFERENCES

1. von Krogh G. Podophyllotoxin in serum: Absorption subsequent to three day repeated applications of a 0.5% ethanolic preparation on condylomata acuminata. Sex Trans Disease 1982: 9: 26-33.

Last reviewed on RxList: 11/24/2008
This monograph has been modified to include the generic and brand name in many instances.

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