Clinical trial NCT05383625: Gardasil Versus Cervarix in the Treatment of Warts
Official title: Quadrivalent and Bivalent Human Papilloma Virus Vaccines in the Treatment of Common Recalcitrant Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Verruca Viral
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-05-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Therapeutic response
timeFrame: 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 outcomes:
measure: Safety measure
timeFrame: Through study completion every treatment session held at two weeks interval for a maximum of 5 sessions
measure: Safety measure
timeFrame: Through study completion for a maximum of 12 weeks held every two weeks till the end of the treatment sessions (12th week visit)
measure: Recurrence
timeFrame: 6 months following the end of treatment sessions
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University
state: Select Region
Study officials:
References:
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.
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.
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.
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. No abstract available.
citation: 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. No abstract available.