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Comparison Between Tuberculin Vaccine and Cryotherapy in Genital Wart Patients

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ClinicalTrials.gov Identifier: NCT03153566
Recruitment Status : Unknown
Verified May 2017 by Mena Ramsis Haleem, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : May 15, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Mena Ramsis Haleem, Assiut University

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.

Condition or disease Intervention/treatment Phase
Genital Wart Biological: tuberculin Device: cryotherapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Tuberculin Vaccine and Cryotherapy in the Treatment of Genital Wart Patients
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Experimental: 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
Biological: tuberculin
inject the mother wart with .3 ml tuberculin vaccine every 2 weeks

Active Comparator: 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
Device: cryotherapy
10 sec 1 cycle into all genital warts

Experimental: 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
Biological: tuberculin
inject the mother wart with .3 ml tuberculin vaccine every 2 weeks

Device: cryotherapy
10 sec 1 cycle into all genital warts




Primary Outcome Measures :
  1. number of patients with complete resolution of genital warts [ Time Frame: 4 months ]
    frequency (number)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Publications of Results:
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Responsible Party: Mena Ramsis Haleem, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03153566    
Other Study ID Numbers: PPDG
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases