Comparison Between Tuberculin Vaccine and Cryotherapy in Genital Wart Patients
Primary Purpose
Genital Wart
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
tuberculin
cryotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Genital Wart
Eligibility Criteria
Inclusion Criteria:
- All types of genital and anal warts will be included in this study especially patients with 5 or more warts and more than 1 cm in size
Exclusion Criteria:
- Patients with immunodeficient diseases or receiving any immunosuppressive drugs
- Pregnancy and lactation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
study group
control group
combined group
Arm Description
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
include (15) patients will be treated with cryotherapy every 2 weeks ,4 sessions will be done then patients will be followed for 2 months
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
Outcomes
Primary Outcome Measures
number of patients with complete resolution of genital warts
frequency (number)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03153566
Brief Title
Comparison Between Tuberculin Vaccine and Cryotherapy in Genital Wart Patients
Official Title
Comparison Between Tuberculin Vaccine and Cryotherapy in the Treatment of Genital Wart Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Anticipated)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cutaneous and genital warts are common dermatological conditions caused by Human Papilloma Virus. Although it is a benign condition it causes disfigurement, has tendency to collect, can be transmitted to others, this makes adequate and timely treatment important, while many warts are resolve spontaneously over several years, most patients seek treatment because the warts are unsightly and often tender or painful.
Detailed Description
Genital warts are highly contagious sexually transmitted diseases (STD) caused by infection of Human Papilloma Virus and, as the most common STD in developed countries, can currently be considered to be globally epidemic.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Wart
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
study group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
Active Comparator
Arm Description
include (15) patients will be treated with cryotherapy every 2 weeks ,4 sessions will be done then patients will be followed for 2 months
Arm Title
combined group
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
tuberculin
Intervention Description
inject the mother wart with .3 ml tuberculin vaccine every 2 weeks
Intervention Type
Device
Intervention Name(s)
cryotherapy
Intervention Description
10 sec 1 cycle into all genital warts
Primary Outcome Measure Information:
Title
number of patients with complete resolution of genital warts
Description
frequency (number)
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All types of genital and anal warts will be included in this study especially patients with 5 or more warts and more than 1 cm in size
Exclusion Criteria:
Patients with immunodeficient diseases or receiving any immunosuppressive drugs
Pregnancy and lactation
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11238198
Citation
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.
Results Reference
result
PubMed Identifier
16973081
Citation
Buck HW Jr. Genital warts. Clin Evid. 2006 Jun;(15):2149-61. No abstract available.
Results Reference
result
PubMed Identifier
12807939
Citation
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.
Results Reference
result
PubMed Identifier
25273231
Citation
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.
Results Reference
result
PubMed Identifier
15897380
Citation
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.
Results Reference
result
PubMed Identifier
23336207
Citation
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.
Results Reference
result
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Comparison Between Tuberculin Vaccine and Cryotherapy in Genital Wart Patients
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