Gardasil Versus Cervarix in the Treatment of Warts
Primary Purpose
Verruca Viral
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
Bivalent Human Papilloma Virus Vaccine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Verruca Viral
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
Sites / Locations
- Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Quadrivalent vaccine
Bivalent Vaccine
Saline control
Arm Description
Patient receive 0.1 ml of quadrivalent HPV vaccine intralesional every two weeks
Patient received 0.1 ml of bivalent HPV vaccine intralesional once every two weeks
Patient received 0.1 ml of intralesional saline once every two weeks
Outcomes
Primary Outcome Measures
Therapeutic response
The percentage of patients in each group achieving complete, partial or no response at the end of the treatment sessions
Secondary Outcome Measures
Safety measure
Immediate adverse events recorded by the treating physician within 1 hour post injection
Safety measure
Delayed adverse events reported by the patients in between sessions
Recurrence
Percentage of patients experiencing recurrences in each group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05383625
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Verruca Viral
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quadrivalent vaccine
Arm Type
Experimental
Arm Description
Patient receive 0.1 ml of quadrivalent HPV vaccine intralesional every two weeks
Arm Title
Bivalent Vaccine
Arm Type
Experimental
Arm Description
Patient received 0.1 ml of bivalent HPV vaccine intralesional once every two weeks
Arm Title
Saline control
Arm Type
Placebo Comparator
Arm Description
Patient received 0.1 ml of intralesional saline once every two weeks
Intervention Type
Drug
Intervention Name(s)
Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
Intervention Description
intralesional 0.1 ml every two weeks
Intervention Type
Drug
Intervention Name(s)
Bivalent Human Papilloma Virus Vaccine
Intervention Description
Intralesional 0.1 ml every two weeks
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
intralesional into the largest warts every two weeks
Primary Outcome Measure Information:
Title
Therapeutic response
Description
The percentage of patients in each group achieving complete, partial or no response at the end of the treatment sessions
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)
Secondary Outcome Measure Information:
Title
Safety measure
Description
Immediate adverse events recorded by the treating physician within 1 hour post injection
Time Frame
Through study completion every treatment session held at two weeks interval for a maximum of 5 sessions
Title
Safety measure
Description
Delayed adverse events reported by the patients in between sessions
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)
Title
Recurrence
Description
Percentage of patients experiencing recurrences in each group
Time Frame
6 months following the end of treatment sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University
City
Zagazig
State/Province
Select Region
ZIP/Postal Code
44511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28791682
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.
Results Reference
background
PubMed Identifier
31369771
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.
Results Reference
background
PubMed Identifier
25070525
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.
Results Reference
background
PubMed Identifier
22794819
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.
Results Reference
background
PubMed Identifier
20956677
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.
Results Reference
background
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Gardasil Versus Cervarix in the Treatment of Warts
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