Comparison Between Tuberculin Vaccine and Cryotherapy in Genital Wart Patients
NCT ID: NCT03153566
Last Updated: 2017-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
45 participants
INTERVENTIONAL
2017-06-01
2018-12-31
Brief Summary
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Detailed Description
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It is estimated that the frequency of Human Papilloma Virus infection among women in the world ranges from 2% to 44%.
The conventional modalities in treatment of warts include destructive therapies such as salicylic acid, trichloroacetic acid, cryotherapy, silver nitrate, phenol, cantharidin, surgical interventions and laser, antiproliferative agents such as bleomycin, vitamin D analogs, podophyllin, 5 fluorouracil and antiviral agents such as cidofovir and retinoids.
There are different mechanisms have been proposed for the resolution of warts with skin test antigens such as mumps, candida, trichophyton both at the injected as well as distant sites.
Tuberculin:
Purified protein derivative or tuberculin stimulates the cell mediated immunity non specifically by activating T helper 1 cells, Natural Killer cells, and cytokine production an increase in interleukin-12 as a process in boosting the cell-mediated immunity contributes to the mechanism of action.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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study group
include (15) patients will be injected with Tuberculin vaccine 0.3 ml every 2 weeks, vaccine will be injected in the largest wart, 4 sessions will be done then patients will be followed for 2 months
tuberculin
inject the mother wart with .3 ml tuberculin vaccine every 2 weeks
control group
include (15) patients will be treated with cryotherapy every 2 weeks ,4 sessions will be done then patients will be followed for 2 months
cryotherapy
10 sec 1 cycle into all genital warts
combined group
include (15) patients will be treated with combined cryotherapy and Tuberculin vaccine , one week cryotherapy and the other week Tuberculin vaccine , then patients will be followed for 2 weeks
tuberculin
inject the mother wart with .3 ml tuberculin vaccine every 2 weeks
cryotherapy
10 sec 1 cycle into all genital warts
Interventions
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tuberculin
inject the mother wart with .3 ml tuberculin vaccine every 2 weeks
cryotherapy
10 sec 1 cycle into all genital warts
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy and lactation
20 Years
60 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mena Ramsis Haleem
Principal Investigator
References
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Scott M, Nakagawa M, Moscicki AB. Cell-mediated immune response to human papillomavirus infection. Clin Diagn Lab Immunol. 2001 Mar;8(2):209-20. doi: 10.1128/CDLI.8.2.209-220.2001. No abstract available.
Buck HW Jr. Genital warts. Clin Evid. 2006 Jun;(15):2149-61. No abstract available.
Bosch FX, de Sanjose S. Chapter 1: Human papillomavirus and cervical cancer--burden and assessment of causality. J Natl Cancer Inst Monogr. 2003;(31):3-13. doi: 10.1093/oxfordjournals.jncimonographs.a003479.
Sterling JC, Gibbs S, Haque Hussain SS, Mohd Mustapa MF, Handfield-Jones SE. British Association of Dermatologists' guidelines for the management of cutaneous warts 2014. Br J Dermatol. 2014 Oct;171(4):696-712. doi: 10.1111/bjd.13310. Epub 2014 Oct 1. No abstract available.
Horn TD, Johnson SM, Helm RM, Roberson PK. Intralesional immunotherapy of warts with mumps, Candida, and Trichophyton skin test antigens: a single-blinded, randomized, and controlled trial. Arch Dermatol. 2005 May;141(5):589-94. doi: 10.1001/archderm.141.5.589.
Abd-Elazeim FM, Mohammed GF, Fathy A, Mohamed RW. Evaluation of IL-12 serum level in patients with recalcitrant multiple common warts, treated by intralesional tuberculin antigen. J Dermatolog Treat. 2014 Jun;25(3):264-7. doi: 10.3109/09546634.2013.768760. Epub 2013 May 6.
Other Identifiers
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PPDG
Identifier Type: -
Identifier Source: org_study_id
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