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
1 other identifier
interventional
45
0 countries
N/A
Brief Summary
This study compares the safety and efficacy of intralesional Candidal antigen versus Intralesional MMR vaccine versus podophyllin for treatment of genital warts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2019
CompletedFirst Posted
Study publicly available on registry
February 26, 2019
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMarch 12, 2019
March 1, 2019
1 year
February 22, 2019
March 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
45 days
Study Arms (3)
Intralesional MMR vaccine
ACTIVE COMPARATORIntralesional Mumps, measles and rubella (MMR) vaccine in genital warts
intralesional candida antigen
ACTIVE COMPARATORintralesional candida antigen in genital warts
Topical Podophyllin
ACTIVE COMPARATORTopical Podophyllin in genital warts
Interventions
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.
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.
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 .
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with any evidence of immunosuppression
- Eczematous skin disorder
- Those with any history of hypersensitivity to Candida albicans antigen
- Pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
February 22, 2019
First Posted
February 26, 2019
Study Start
February 1, 2020
Primary Completion
February 1, 2021
Study Completion
December 1, 2021
Last Updated
March 12, 2019
Record last verified: 2019-03