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Low Dose Cyclophosphamide Treats Genital Warts

NCT00999986 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2009-11-25

No results posted yet for this study

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.

Conditions

  • Genital Wart

Interventions

DRUG

cyclophosphamide

50 mg oral per day for 7 days

Sponsors & Collaborators

  • Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Bo Huang, PH.D, MD · Tongji Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-06-30
Completion
2009-08-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00999986 on ClinicalTrials.gov