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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadrivalent vaccine | Experimental | Patient receive 0.1 ml of quadrivalent HPV vaccine intralesional every two weeks |
|
| Bivalent Vaccine | Experimental | Patient received 0.1 ml of bivalent HPV vaccine intralesional once every two weeks |
|
| Saline control | Placebo Comparator | Patient received 0.1 ml of intralesional saline once every two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine | Drug | intralesional 0.1 ml every two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic response | The percentage of patients in each group achieving complete, partial or no response at the end of the treatment sessions | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measure | Immediate adverse events recorded by the treating physician within 1 hour post injection | Through study completion every treatment session held at two weeks interval for a maximum of 5 sessions |
| Safety measure |
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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.
Exclusion Criteria:
Patients with acute febrile illness.
Past history of asthma.
Allergic skin disorders, such as generalized eczema, or severe urticaria.
Pregnancy or lactation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University | Zagazig | Select Region | 44511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28791682 | Background | 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. | |
| 31369771 | Background | 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. |
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| ID | Term |
|---|---|
| D014614 | Vaccines, Synthetic |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
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| Bivalent Human Papilloma Virus Vaccine | Drug | Intralesional 0.1 ml every two weeks |
|
| Saline | Drug | intralesional into the largest warts every two weeks |
|
Delayed adverse events reported by the patients in between sessions
| Through study completion for a maximum of 12 weeks held every two weeks till the end of the treatment sessions (12th week visit) |
| Recurrence | Percentage of patients experiencing recurrences in each group | 6 months following the end of treatment sessions |
| 25070525 | Background | 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. |
| 22794819 | Background | 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. |
| 20956677 | Background | 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. |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |