Low Dose Cyclophosphamide Treats Genital Warts

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT00999986

Collaborator

(none)

104

Enrollment

Location

Arms

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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 :

Jan 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: placebo

Active Comparator: cyclophosphamide

Drug: cyclophosphamide

50 mg oral per day for 7 days

Other Names:

Outcome Measures

Primary Outcome Measures

low-dose cyclophosphamide effectively prevents the recurrence of large genital warts after laser therapy [6 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Clinical diagnosis of large genital warts

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

European Society for Dermatological Research

Publications

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.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00999986

Other Study ID Numbers:

Sheng-Qi-An

First Posted:

Oct 22, 2009

Last Update Posted:

Nov 25, 2009

Last Verified:

Nov 1, 2009

Additional relevant MeSH terms:

Warts

Condylomata Acuminata

Cyclophosphamide

Study Results

No Results Posted as of Nov 25, 2009