Comparison Between Tuberculin Vaccine and Cryotherapy in Genital Wart Patients

NCT ID: NCT03153566

Last Updated: 2017-05-17

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Genital Wart

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

tuberculin

Intervention Type BIOLOGICAL

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

Group Type ACTIVE_COMPARATOR

cryotherapy

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

tuberculin

Intervention Type BIOLOGICAL

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

cryotherapy

Intervention Type DEVICE

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

Intervention Type BIOLOGICAL

cryotherapy

10 sec 1 cycle into all genital warts

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mena Ramsis Haleem

Principal Investigator

Responsibility Role 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.

Reference Type RESULT
PMID: 11238198 (View on PubMed)

Buck HW Jr. Genital warts. Clin Evid. 2006 Jun;(15):2149-61. No abstract available.

Reference Type RESULT
PMID: 16973081 (View on PubMed)

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.

Reference Type RESULT
PMID: 12807939 (View on PubMed)

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.

Reference Type RESULT
PMID: 25273231 (View on PubMed)

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.

Reference Type RESULT
PMID: 15897380 (View on PubMed)

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.

Reference Type RESULT
PMID: 23336207 (View on PubMed)

Other Identifiers

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PPDG

Identifier Type: -

Identifier Source: org_study_id

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