NCT00999986

Low Dose Cyclophosphamide Treats Genital Warts

Phase III Study of the Treatment of Genital Warts by Low Dose Cyclophosphamide

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Condylomata acuminata (CA) caused by human papillomavirus (HPV) is a common sexually transmitted disease with half a million new cases diagnosed in the United States per year. Recurrence is a major challenge for CA treatment. The investigators have demonstrated that FOXP3+ regulatory T (Treg) cells mediate the immunosuppression in large genital warts. And low-dose cyclophosphamide (CY), a conventional chemotherapy drug, has been reported to selectively deplete Treg cells in cancer patients. Therefore, the investigators hypothesized that low-dose CY can be used to treat genital warts. In this study, 104 CA patients have been recruited for clinical trial with a 1:2 randomization. Among them, 64 patients received low-dose cyclophosphamide and 32 received placebo. In 8 extra patients, high-dose cyclophosphamide was given.

Detailed description

Patients were first treated with CO2 laser therapy, and then treated with low-dose CY, orally 50 mg per day for 7 days.The CA recurrence were observed.

Conditions

• Genital Wart

Interventions

Type	Name	Description
DRUG	cyclophosphamide	50 mg oral per day for 7 days

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-06-01
• Completion: 2009-08-01
• First posted: 2009-10-22
• Last updated: 2009-11-25

Locations

1 site across 1 country: China