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Low Dose Cyclophosphamide Treats Genital Warts

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ClinicalTrials.gov Identifier: NCT00999986
Recruitment Status : Completed
First Posted : October 22, 2009
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:
Huazhong University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Genital Wart Drug: cyclophosphamide Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phase III Study of the Treatment of Genital Warts by Low Dose Cyclophosphamide
Study Start Date : January 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
No Intervention: placebo
Active Comparator: cyclophosphamide Drug: cyclophosphamide
50 mg oral per day for 7 days
Other Name: CY




Primary Outcome Measures :
  1. low-dose cyclophosphamide effectively prevents the recurrence of large genital warts after laser therapy [ Time Frame: 6 month ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of large genital warts

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999986


Locations
China, Hubei
Tongji Hospital
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Principal Investigator: Bo Huang, PH.D, MD Tongji Medical College

Additional Information:
Publications:
Responsible Party: Feifan Meng, Sheng-Qi-An Biotech Inc
ClinicalTrials.gov Identifier: NCT00999986     History of Changes
Other Study ID Numbers: Sheng-Qi-An
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists