Back to resultsLow Dose Cyclophosphamide Treats Genital Warts
Primary Purpose
Genital Wart
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Genital Wart
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of large genital warts
Exclusion Criteria:
- HPV type 6 or 11 was detected negatively by PCR method.
Sites / Locations
- Tongji Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
placebo
cyclophosphamide
Arm Description
Outcomes
Primary Outcome Measures
low-dose cyclophosphamide effectively prevents the recurrence of large genital warts after laser therapy
Secondary Outcome Measures
Full Information
NCT ID
NCT00999986
First Posted
October 21, 2009
Last Updated
November 24, 2009
Sponsor
Huazhong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT00999986
Brief Title
Low Dose Cyclophosphamide Treats Genital Warts
Official Title
Phase III Study of the Treatment of Genital Warts by Low Dose Cyclophosphamide
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Huazhong University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Wart
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
No Intervention
Arm Title
cyclophosphamide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
CY
Intervention Description
50 mg oral per day for 7 days
Primary Outcome Measure Information:
Title
low-dose cyclophosphamide effectively prevents the recurrence of large genital warts after laser therapy
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of large genital warts
Exclusion Criteria:
HPV type 6 or 11 was detected negatively by PCR method.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Huang, PH.D, MD
Organizational Affiliation
Tongji Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
18490771
Citation
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. doi: 10.4049/jimmunol.180.11.7681.
Results Reference
background
Links:
URL
http://www.esdr.org/index.php?option=com_frontpage&Itemid=1
Description
European Society for Dermatological Research
Learn more about this trial
Low Dose Cyclophosphamide Treats Genital Warts
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