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NCT00999986 Clinical Trial

Low Dose Cyclophosphamide Treats Genital Warts

Genital Wart Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00999986
Other study ID # Sheng-Qi-An
Secondary ID
Status Completed
Phase Phase 3
First received October 21, 2009
Last updated November 24, 2009
Start date January 2007
Est. completion date August 2009

Study information
Verified date November 2009
Source Huazhong University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 104
Est. completion date August 2009
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of large genital warts

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• cyclophosphamide
50 mg oral per day for 7 days

Locations
Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (1)

Cao Y, Zhao J, Lei Z, Shen S, Liu C, Li D, Liu J, Shen GX, Zhang GM, Feng ZH, Huang B. Local accumulation of FOXP3+ regulatory T cells: evidence for an immune evasion mechanism in patients with large condylomata acuminata. J Immunol. 2008 Jun 1;180(11):7681-6. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary low-dose cyclophosphamide effectively prevents the recurrence of large genital warts after laser therapy 6 month Yes
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