Efficacy of Intralesional MMR Vaccine,Intralesional Candidal Antigen&Topical Podophyllin in Treatment of Genital Warts
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| ClinicalTrials.gov Identifier: NCT03853785 |
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Recruitment Status : Unknown
Verified March 2019 by Meriam Mamdouh Boshra, Assiut University.
Recruitment status was: Not yet recruiting
First Posted : February 26, 2019
Last Update Posted : March 12, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Condylomata Acuminata | Biological: MMR vaccine Biological: Candida antigen Drug: Topical Podophyllin | Phase 3 |
Anogenital human papillomavirus (HPV) is a highly prevalent sexually transmitted infection ,seen predominantly in young adults.
Condyloma acuminata or benign anogenital warts are typically caused by HPV-6 OR 11 which are considered low risk types.Persistent infection with high risk HPV types predominantly HPV-16 and 18 is the primary and major cause of cervical cancers and a subset of vaginal,vulvar, penile , anal ,oropharyngeal and rarely squamous cell carcinoma of the digits.
Warts may reflect a localized or systemic cell-mediated immune (CMI) deficiency to HPV.
Anogenital warts may appear as a single lesion or in clusters as flat, flesh-coloured to pigmented plaques or rough-surfaced papules and exophytic nodules.
The conventional modalities in treatment of warts include destructive therapies such as salicylic acid, trichloroacetic acid, cryotherapy, silver nitrate, phenol, cantharidin, surgical interventions and lasers; antiproliferative agents such as bleomycin, podophyllin, podophyllotoxin, and 5-fluro uracil; antiviral agents such as cidofovir and retinoids.
Because of the cumbersome nature of these procedures and a high risk of recurrence, immunotherapy is becoming more and more popular, especially in the treatment of refractory cutaneous and genital warts.It enhances recognition of the virus by the immune system. immunotherapy not only causes a resolution of the treated wart but also leads to clearance of distant warts, at least in a subset of the responders.
Immunotherapy in warts can be administered by various methods. The first method is topical application of certain inorganic molecules that are capable of eliciting a contact hypersensitivity reaction with secondary activation of an immunological response .or even topical applications of immune modulators like imiquimod,A second modality is the use of oral immune modulators such as cimetidine,and levamisole .
A third method is Intralesional injection of immunotherapeutic agent that utilizes the ability of the immune system to mount a delayed type hypersensitivity response to various antigens and also the wart tissue leading to production of Th1 cytokines which activate cytotoxic and natural killer cells to eradicate HPV infection.
Immunotherapy with different skin test antigens like Candida, mumps or trichophyton antigen is a relatively new treatment option for warts. Candida antigen reported success in majority of patients treated with this test antigen .
Mumps, measles and rubella (MMR) vaccine is a freeze-dried preparation of live attenuated strains of measles, mumps and rubella viruses (0.5 ml/dose). In some of the previous studies, it has been shown that mumps-measles-rubella (MMR) vaccine results in regression of warts via immunomodulation and induction of immune system.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 45 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The Efficacy of Intralesional Measles, Mumps, Rubella (MMR) Vaccine, Intralesional Candidal Antigen and Topical Podophyllin in Treatment of Genital Warts: A Comparative Study |
| Estimated Study Start Date : | February 2020 |
| Estimated Primary Completion Date : | February 2021 |
| Estimated Study Completion Date : | December 2021 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Intralesional MMR vaccine
Intralesional Mumps, measles and rubella (MMR) vaccine in genital warts
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Biological: MMR vaccine
Intralesional injection of 0.5 ml MMR vaccine in the largest lesion . Injections will be repeated into the same lesion every 2 weeks for a maximum of three treatment sessions. |
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Active Comparator: intralesional candida antigen
intralesional candida antigen in genital warts
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Biological: Candida antigen
Intralesional injection of Candidal antigen with a dose of (0.1ml -0.3ml) by an insulin syringe in the largest wart at the first visit. Injections will be repeated for all patients into the same lesion every 2 weeks for a maximum of three treatment sessions. |
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Active Comparator: Topical Podophyllin
Topical Podophyllin in genital warts
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Drug: Topical Podophyllin
It will be applied to the wart by using a cotton tipped swab once a week . The procedure will be limited to 10 cm2 per session .Surrounding skin will be protected by Vaseline. Podophyllin will be washed 4 hour after application . The procedure will be repeated every week till 6 weeks . |
- Cure rate [ Time Frame: 45 days ]Assess cure rate of MMR vaccine and candida antigen and topical podophyllin in treatment of genital warts (complete disappearance of lesions) in 45 days duration and compare efficacy of the measures.
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| Ages Eligible for Study: | 3 Years to 50 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with anogenital warts with ages ranging from 3 to 50 years
- Genital warts resistant to treatment
- Genital warts that had relapsed at least once after treatment with any of the tissue-destructive modalities.
Exclusion Criteria:
- Patients with any evidence of immunosuppression
- Eczematous skin disorder
- Those with any history of hypersensitivity to Candida albicans antigen
- Pregnant or lactating women.
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): NCT03853785
| Contact: Hisham Zayan, MD | 201223971409 ext 00+20 | hishamzayan@yahoo.com | |
| Contact: Yasmin tawfik, MD | 201006033331 ext 00+20 | dr.yasminmostawfik@yahoo.com |
| Responsible Party: | Meriam Mamdouh Boshra, principle investigator, Assiut University |
| ClinicalTrials.gov Identifier: | NCT03853785 |
| Other Study ID Numbers: |
MMR vaccine in genital warts |
| First Posted: | February 26, 2019 Key Record Dates |
| Last Update Posted: | March 12, 2019 |
| Last Verified: | March 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Condylomata Acuminata Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Communicable Diseases Infections Warts Papillomavirus Infections DNA Virus Infections Virus Diseases |
Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases Podophyllin Antineoplastic Agents, Phytogenic Antineoplastic Agents Keratolytic Agents Dermatologic Agents |