Gardasil Versus Cervarix in the Treatment of Warts

Zagazig University

Status and phase: Completed; Phase 3

Conditions: Verruca Viral

Treatments: Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine; Drug: Saline; Drug: Bivalent Human Papilloma Virus Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05383625

ZU-IRB#5859/15-1-2020

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups, including a placebo group

Quadrivalent vaccine

Experimental group

Description:

Patient receive 0.1 ml of quadrivalent HPV vaccine intralesional every two weeks

Treatment:

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

Bivalent Vaccine

Experimental group

Description:

Patient received 0.1 ml of bivalent HPV vaccine intralesional once every two weeks

Treatment:

Drug: Bivalent Human Papilloma Virus Vaccine

Saline control

Placebo Comparator group

Description:

Patient received 0.1 ml of intralesional saline once every two weeks

Treatment:

Drug: Saline