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Completed

NCT Number: NCT05383625

Gardasil Versus Cervarix in the Treatment of Warts

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

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Key information

Conditions

Verruca Viral

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University

Zagazig, Select Region, 44511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

Drug

intralesional 0.1 ml every two weeks

Bivalent Human Papilloma Virus Vaccine

Drug

Intralesional 0.1 ml every two weeks

Saline

Drug

intralesional into the largest warts every two weeks

Primary outcomes

  1. Therapeutic response

    Time frame: 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)

    The percentage of patients in each group achieving complete, partial or no response at the end of the treatment sessions

Secondary outcomes

  1. Safety measure

    Time frame: Through study completion every treatment session held at two weeks interval for a maximum of 5 sessions

    Immediate adverse events recorded by the treating physician within 1 hour post injection

  2. Safety measure

    Time frame: Through study completion for a maximum of 12 weeks held every two weeks till the end of the treatment sessions (12th week visit)

    Delayed adverse events reported by the patients in between sessions

  3. Recurrence

    Time frame: 6 months following the end of treatment sessions

    Percentage of patients experiencing recurrences in each group

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 20, 2022
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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