Gardasil Versus Cervarix in the Treatment of Warts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-12-01

Brief Summary

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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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Detailed Description

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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

Conditions

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Verruca Viral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Quadrivalent vaccine

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

intralesional 0.1 ml every two weeks

Bivalent Vaccine

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

Group Type EXPERIMENTAL

Bivalent Human Papilloma Virus Vaccine

Intervention Type DRUG

Intralesional 0.1 ml every two weeks

Saline control

Patient received 0.1 ml of intralesional saline once every two weeks

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

intralesional into the largest warts every two weeks

Interventions

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

intralesional 0.1 ml every two weeks

Intervention Type DRUG

Bivalent Human Papilloma Virus Vaccine

Intralesional 0.1 ml every two weeks

Intervention Type DRUG

Saline

intralesional into the largest warts every two weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No