Clinical trial · Interventional
Low Dose Cyclophosphamide Treats Genital Warts
Phase III Study of the Treatment of Genital Warts by Low Dose Cyclophosphamide
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genital Wart | Condyloma Acuminatum | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- placebo
- type
- ACTIVE_COMPARATOR
- label
- cyclophosphamide
- interventionNames
- Drug: cyclophosphamide
Primary outcomes (1)
- measure
- low-dose cyclophosphamide effectively prevents the recurrence of large genital warts after laser therapy
- timeFrame
- 6 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis of large genital warts Exclusion Criteria: * HPV type 6 or 11 was detected negatively by PCR method.
References
Publications (1)
- BACKGROUNDCao 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. PMID 18490771