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Low Dose Cyclophosphamide Treats Genital Warts

NCT ID: NCT00999986

Last Updated: 2009-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-08-31

Brief Summary

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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

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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.

Conditions

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Genital Wart

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

cyclophosphamide

Group Type ACTIVE_COMPARATOR

cyclophosphamide

Intervention Type DRUG

50 mg oral per day for 7 days

Interventions

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cyclophosphamide

50 mg oral per day for 7 days

Intervention Type DRUG

Other Intervention Names

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CY

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of large genital warts

Exclusion Criteria

* HPV type 6 or 11 was detected negatively by PCR method.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Sheng-Qi-An Biotech Inc

Principal Investigators

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Bo Huang, PH.D, MD

Role: PRINCIPAL_INVESTIGATOR

Tongji Medical College

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 18490771 (View on PubMed)

Related Links

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http://www.esdr.org/index.php?option=com_frontpage&Itemid=1

European Society for Dermatological Research

Other Identifiers

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Sheng-Qi-An

Identifier Type: -

Identifier Source: org_study_id