- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03853785
Efficacy of Intralesional MMR Vaccine,Intralesional Candidal Antigen&Topical Podophyllin in Treatment of Genital Warts
The Efficacy of Intralesional Measles, Mumps, Rubella (MMR) Vaccine, Intralesional Candidal Antigen and Topical Podophyllin in Treatment of Genital Warts: A Comparative Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Hisham Zayan, MD
- Phone Number: 00+20 201223971409
- Email: hishamzayan@yahoo.com
Study Contact Backup
- Name: Yasmin tawfik, MD
- Phone Number: 00+20 201006033331
- Email: dr.yasminmostawfik@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intralesional MMR vaccine
Intralesional Mumps, measles and rubella (MMR) vaccine in genital warts
|
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.
|
Active Comparator: intralesional candida antigen
intralesional candida antigen in genital warts
|
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.
|
Active Comparator: Topical Podophyllin
Topical Podophyllin in genital warts
|
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 .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
45 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Virus Diseases
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- DNA Virus Infections
- Skin Diseases, Infectious
- Warts
- Papillomavirus Infections
- Skin Diseases, Viral
- Tumor Virus Infections
- Condylomata Acuminata
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Dermatologic Agents
- Keratolytic Agents
- Podophyllin
Other Study ID Numbers
- MMR vaccine in genital warts
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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