Low Dose Cyclophosphamide Treats Genital Warts

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.

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Key information

Conditions

Genital Wart Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tongji Hospital

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of large genital warts

Exclusion criteria

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

Treatment and study plan

Cyclophosphamide

Drug

50 mg oral per day for 7 days

Other names: CY

Primary outcomes

low-dose cyclophosphamide effectively prevents the recurrence of large genital warts after laser therapy

Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Oct 22, 2009
Registry last updated: Nov 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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