Low Dose Cyclophosphamide Treats Genital Warts
- Registration Number
- NCT00999986
- Lead Sponsor
- Huazhong University of Science and Technology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- Clinical diagnosis of large genital warts
- HPV type 6 or 11 was detected negatively by PCR method.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cyclophosphamide cyclophosphamide -
- Primary Outcome Measures
Name Time Method low-dose cyclophosphamide effectively prevents the recurrence of large genital warts after laser therapy 6 month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tongji Hospital
🇨🇳Wuhan, Hubei, China