Gardasil Versus Cervarix in the Treatment of Warts

Verruca Viral Clinical Trial

Official title:

Quadrivalent and Bivalent Human Papilloma Virus Vaccines in the Treatment of Common Recalcitrant Warts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05383625
• Other study ID #: ZU-IRB#5859/15-1-2020
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: May 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Warts are common, benign, epidermal proliferations caused by HPV infecting skin and mucous membranes. Treatment of warts poses a true challenge despite existing variable therapeutic modalities, whether destructive or immunotherapeutic. Human papilloma virus (HPV) vaccines are FDA approved for the prevention of genital warts and wart related precancerous and cancerous lesions but they are not indicated for treatment of preexisting warts yet

Description:

Approximately 35% of viral warts tend to be recalcitrant either showing no response to treatment or having prompt recurrences after treatment, causing frustration for both patients and physicians. Success rates vary significantly across patients and across different therapeutic interventions ranging from 7% to 90%.

Immunotherapy is proposed to enhance virus recognition by the cell mediated immunity, which allows the clearance of both treated and untreated warts and helps to prevent recurrences through induction of a long-term acquired immunity to HPV.

Few reports suggest the possibility of using quadrivalent or bivalent HPV vaccines as therapeutic modality rather than only preventive modality. This is a randomized controlled study to assess the efficacy and safety of quadrivalent and bivalent HPV vaccines in the treatment of warts

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult Patients with recalcitrant multiple warts of any type. Warts were considered recalcitrant if they persisted for at least 6 months without any response to 2 different therapeutic modalities or more.

• Immunocompetent patients.

• Patients who do not receive any treatment of warts for at least 1 month before the start of study.

• Patients who are able to understand and follow the study protocol and approve to sign the informed consent

Exclusion Criteria:

• Patients with acute febrile illness.

• Past history of asthma.

• Allergic skin disorders, such as generalized eczema, or severe urticaria.

• Pregnancy or lactation

• History of hypersensitivity to the treatment vaccines.

• Children

• Immunocompromised patients

• Patients unable to follow the study protocol

Related Conditions & MeSH terms

• Verruca Viral
• Warts

Intervention

Drug:
• Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
intralesional 0.1 ml every two weeks
• Bivalent Human Papilloma Virus Vaccine
Intralesional 0.1 ml every two weeks
• Saline
intralesional into the largest warts every two weeks

Locations

Country	Name	City	State
Egypt	Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University	Zagazig	Select Region

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Kreuter A, Waterboer T, Wieland U. Regression of cutaneous warts in a patient with WILD syndrome following recombinant quadrivalent human papillomavirus vaccination. Arch Dermatol. 2010 Oct;146(10):1196-7. doi: 10.1001/archdermatol.2010.290. — View Citation

Landis MN, Lookingbill DP, Sluzevich JC. Recalcitrant plantar warts treated with recombinant quadrivalent human papillomavirus vaccine. J Am Acad Dermatol. 2012 Aug;67(2):e73-4. doi: 10.1016/j.jaad.2011.08.022. — View Citation

Nofal A, Marei A, Amer A, Amen H. Significance of interferon gamma in the prediction of successful therapy of common warts by intralesional injection of Candida antigen. Int J Dermatol. 2017 Oct;56(10):1003-1009. doi: 10.1111/ijd.13709. Epub 2017 Aug 8. — View Citation

Nofal A, Marei A, Ibrahim AM, Nofal E, Nabil M. Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts. J Am Acad Dermatol. 2020 Jan;82(1):94-100. doi: 10.1016/j.jaad.2019.07.070. Epub 2019 Jul 29. — View Citation

Nofal A, Nofal E, Yosef A, Nofal H. Treatment of recalcitrant warts with intralesional measles, mumps, and rubella vaccine: a promising approach. Int J Dermatol. 2015 Jun;54(6):667-71. doi: 10.1111/ijd.12480. Epub 2014 Jul 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic response	The percentage of patients in each group achieving complete, partial or no response at the end of the treatment sessions	Through study completion for a maximum of 12 weeks, evaluation held at two weeks interval and at the end of treatment sessions (12th week visit)
Secondary	Safety measure	Immediate adverse events recorded by the treating physician within 1 hour post injection	Through study completion every treatment session held at two weeks interval for a maximum of 5 sessions
Secondary	Safety measure	Delayed adverse events reported by the patients in between sessions	Through study completion for a maximum of 12 weeks held every two weeks till the end of the treatment sessions (12th week visit)
Secondary	Recurrence	Percentage of patients experiencing recurrences in each group	6 months following the end of treatment sessions