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Verruca ViralPhase 3NCT05383625

Gardasil Versus Cervarix in the Treatment of Warts

A Phase 3 study testing Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine, Bivalent Human Papilloma Virus Vaccine and Saline in people with Verruca Viral, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Verruca Viral
What is being tested?
Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine, Bivalent Human Papilloma Virus Vaccine and Saline
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Sep 2020to 1 Dec 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Egypt1 site

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

    Zagazig, Select Region, 44511

Other trials in Egypt

About this study

Official title: Quadrivalent and Bivalent Human Papilloma Virus Vaccines in the Treatment of Common Recalcitrant 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

Read the 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

Conditions
Verruca Viral
Being tested
Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine, Bivalent Human Papilloma Virus Vaccine, Saline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    intralesional 0.1 ml every two weeks

  • Bivalent Human Papilloma Virus VaccineDrug

    Intralesional 0.1 ml every two weeks

  • SalineDrug

    intralesional into the largest warts every two weeks

Study groups in NCT05383625
Study groupRoleWhat they receive
Quadrivalent vaccineExperimentalPatient receive 0.1 ml of quadrivalent HPV vaccine intralesional every two weeks
Receives: Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
Bivalent VaccineExperimentalPatient received 0.1 ml of bivalent HPV vaccine intralesional once every two weeks
Receives: Drug: Bivalent Human Papilloma Virus Vaccine
Saline controlPlacebo comparatorPatient received 0.1 ml of intralesional saline once every two weeks
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Therapeutic response

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

    Measured: 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 (3)

  1. Safety measure

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

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

  2. Safety measure

    Delayed adverse events reported by the patients in between sessions

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

  3. Recurrence

    Percentage of patients experiencing recurrences in each group

    Measured: 6 months following the end of treatment sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2022
  2. Study start1 Sep 2020
  3. Primary completion1 Oct 2021
  4. Study completion1 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05383625
Sponsor's protocol ID
ZU-IRB#5859/15-1-2020
Status last verified
May 2022
First submitted
12 May 2022
Last updated
20 May 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 28791682

  • 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.

    PubMed 31369771

  • 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.

    PubMed 25070525

  • 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.

    PubMed 22794819

  • 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.

    PubMed 20956677

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine, Bivalent Human Papilloma Virus Vaccine and Saline in people with Verruca Viral, run by Zagazig University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05383625, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.

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