Low Dose Cyclophosphamide Treats Genital Warts

Huazhong University of Science and Technology

Status and phase: Completed; Phase 3

Conditions: Genital Wart

Treatments: Drug: cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT00999986

Sheng-Qi-An

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of large genital warts

Exclusion criteria

• HPV type 6 or 11 was detected negatively by PCR method.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

placebo

No Intervention group

cyclophosphamide

Active Comparator group

Treatment:

Drug: cyclophosphamide