NCT03153566

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 12, 2017

Last Update Submit

May 15, 2017

Conditions

Genital Wart

Outcome Measures

Primary Outcomes (1)

  • number of patients with complete resolution of genital warts

    frequency (number)

    4 months

Study Arms (3)

study group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

combined group

EXPERIMENTAL

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: tuberculinDevice: cryotherapy

Interventions

tuberculinBIOLOGICAL

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

combined groupstudy group
cryotherapyDEVICE

10 sec 1 cycle into all genital warts

combined groupcontrol group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with immunodeficient diseases or receiving any immunosuppressive drugs
  • Pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 11238198RESULT

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

    PMID: 16973081RESULT

  • 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.

    PMID: 12807939RESULT

  • 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.

    PMID: 25273231RESULT

  • 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.

    PMID: 15897380RESULT

  • 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.

    PMID: 23336207RESULT

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

TuberculinCryotherapy

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsGenital DiseasesUrogenital DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antigens, BacterialBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological FactorsTherapeutics

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
Principal Investigator

Study Record Dates

First Submitted

May 12, 2017

First Posted

May 15, 2017

Study Start

June 1, 2017

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

May 17, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share