Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03153566
Other study ID # PPDG
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received May 12, 2017
Last updated May 15, 2017
Start date June 1, 2017
Est. completion date December 2018

Study information

Verified date May 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date December 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
tuberculin
inject the mother wart with .3 ml tuberculin vaccine every 2 weeks
Device:
cryotherapy
10 sec 1 cycle into all genital warts

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (6)

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 — View Citation

Bosch FX, de Sanjosé S. Chapter 1: Human papillomavirus and cervical cancer--burden and assessment of causality. J Natl Cancer Inst Monogr. 2003;(31):3-13. Review. — View Citation

Buck HW Jr. Genital warts. Clin Evid. 2006 Jun;(15):2149-61. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary number of patients with complete resolution of genital warts frequency (number) 4 months
See also
  Status Clinical Trial Phase
Completed NCT05518201 - Evaluate the Safety and Immunogenicity of a 9-valent HPV Vaccine in Chinese Healthy Male Aged 9-45 Year-old Phase 1
Completed NCT05372016 - Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Phase 3
Recruiting NCT05027776 - Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years Phase 3
Active, not recruiting NCT05580341 - Phase III Study Comparing the Immunogenicity of 9-valent HPV Recombinant Vaccine and Gardasil-9 Phase 3
Completed NCT03676101 - Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Phase 1
Recruiting NCT04895020 - Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years Phase 3
Completed NCT04425291 - Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Phase 3
Recruiting NCT05371353 - Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine
Not yet recruiting NCT06454175 - A Phase I Clinical Trial to Evaluate the Safety of 15-valent HPV Vaccine in Healthy Chinese People Aged 18-45 Years Phase 1
Not yet recruiting NCT06465914 - A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males Phase 3
Active, not recruiting NCT04073082 - Safety and Efficacy of Laser Therapy in Gynaecology
Completed NCT00999986 - Low Dose Cyclophosphamide Treats Genital Warts Phase 3
Terminated NCT05584332 - A Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity, Safety of Quadrivalent HPV Recombinant Vaccine in Chinese Healthy Females Phase 3
Completed NCT04796090 - Genital Wart and Sexuality in Adolescence
Enrolling by invitation NCT04905030 - Education, Immigration and HPV Vaccination: an Informational Randomized Trial N/A
Recruiting NCT04422366 - Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females Phase 3