Efficacy of Intralesional MMR Vaccine,Intralesional Candidal Antigen&Topical Podophyllin in Treatment of Genital Warts
Primary Purpose
Condylomata Acuminata
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MMR vaccine
Candida antigen
Topical Podophyllin
Sponsored by

About this trial
This is an interventional treatment trial for Condylomata Acuminata
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Intralesional MMR vaccine
intralesional candida antigen
Topical Podophyllin
Arm Description
Intralesional Mumps, measles and rubella (MMR) vaccine in genital warts
intralesional candida antigen in genital warts
Topical Podophyllin in genital warts
Outcomes
Primary Outcome Measures
Cure rate
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03853785
Brief Title
Efficacy of Intralesional MMR Vaccine,Intralesional Candidal Antigen&Topical Podophyllin in Treatment of Genital Warts
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study compares the safety and efficacy of intralesional Candidal antigen versus Intralesional MMR vaccine versus podophyllin for treatment of genital warts.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Condylomata Acuminata
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intralesional MMR vaccine
Arm Type
Active Comparator
Arm Description
Intralesional Mumps, measles and rubella (MMR) vaccine in genital warts
Arm Title
intralesional candida antigen
Arm Type
Active Comparator
Arm Description
intralesional candida antigen in genital warts
Arm Title
Topical Podophyllin
Arm Type
Active Comparator
Arm Description
Topical Podophyllin in genital warts
Intervention Type
Biological
Intervention Name(s)
MMR vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Candida antigen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Topical Podophyllin
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Cure rate
Description
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.
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hisham Zayan, MD
Phone
201223971409
Ext
00+20
Email
hishamzayan@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yasmin tawfik, MD
Phone
201006033331
Ext
00+20
Email
dr.yasminmostawfik@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Intralesional MMR Vaccine,Intralesional Candidal Antigen&Topical Podophyllin in Treatment of Genital Warts
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