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Verruca plana is a common skin infection with worldwide distribution. Approximately 10% of general population is infected with flat warts and it represents up to 18 % of the patients seeking treatment for warts. Verruca plana is not merely an infectious disease but also affects the quality of patients' life. Verruca plana causes major cosmetic and social concerns. Lesions' persistence and recurrence cause frustrations and psychological distress which motivate patients to seek different treatment strategies. Verruca plana commonly affects the school aged children which augments its effect on the psychological and social development of children with stigmatization and bullying are great risks. The available treatment strategies neither ensured complete clearance of the disease nor were free of side effects. Frequently used physical removal methods are operator dependent and commonly lead to irritation, local inflammation, scars, dyspigmentation, and disfigurement. In this study we evaluate the efficacy and the safety of tazarotene gel 0.1% in the treatment of verruca plana compared to imiquimod or 5-fluorouracil
Patients will be assigned randomly into one of 4 groups as 1:1:1:1 using randomization.com with the seed number 7607
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tazarotene | Experimental | 20 patients of verruca plana receiving daily topical Tazarotene 0.1% gel at night |
|
| Imiquimod | Active Comparator | 20 patients with verruca plana will be treated with imiquimod cream 5% applied once daily at night |
|
| 5- fluorouracil | Experimental | 20 patients with verruca plana will be treated with topical 5- fluorouracil 5% cream applied once daily at night |
|
| Petrolatum | Placebo Comparator | 20 patients with verruca plana will be treated with petroleum jelly once daily at night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tazarotene 0.1% Gel,Top | Drug | once daily topical application at night with a cotton tipped applicator on every lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with complete clearance of flat warts (Physician Wart Assessment scale PWA = 0) at the end in the four arms of the clinical trial. | Complete clearance is defined by complete disappearance of the warts and return to normal skin markings | Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first |
| The incidence of adverse events measured by the percentage of participants developing them in the four arms of the study | Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| The mean percent of warts achieving PWA 0 (complete clearance) per-participant across the different arms of the clinical trial | Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first | |
| The median time for participants to achieve clearance of all warts in the different arms of the clinical trial. |
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Inclusion Criteria:
All participants must be willing to sign informed consent; for patients younger than 18 years old, parents or guardians will sign an informed consent
Exclusion Criteria:
• History of hypersensitivity to any of the drugs used.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hagar Nofal, Dr. | Contact | 01006387707 | hagarnofal@aucegypt.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University | Recruiting | Zagazig | Select Region | 44511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31682472 | Background | Hodeib AAE, Al-Sharkawy BG, Hegab DS, Talaat RAZ. A comparative study of intralesional injection of Candida albicans antigen, bleomycin and 5-fluorouracil for treatment of plane warts. J Dermatolog Treat. 2021 Sep;32(6):663-668. doi: 10.1080/09546634.2019.1688236. Epub 2019 Nov 12. | |
| 19706088 | Background | Gladsjo JA, Alio Saenz AB, Bergman J, Kricorian G, Cunningham BB. 5% 5-Fluorouracil cream for treatment of verruca vulgaris in children. Pediatr Dermatol. 2009 May-Jun;26(3):279-85. doi: 10.1111/j.1525-1470.2008.00800.x. |
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| ID | Term |
|---|---|
| C086827 | tazarotene |
| D000077271 | Imiquimod |
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Imiquimod | Drug | Imiquimod cream 5% applied once daily at night with a cotton tipped applicator applied once daily. |
|
| Fluorouracil Cream | Drug | 5- Fluorouracil Cream 5% is applied once daily at night with a cotton tipped applicator |
|
| Petrolatum | Drug | applied once daily at night |
|
| Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first |
| The proportion of patients achieving poor response (<50% of warts disappeared) or partial response (> 50%-99% of warts disappeared) | Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first |
| The quality of life index measured by the difference in the wart specific Dermatology Life Quality Index at the end of the trial compared to the baseline | at the end of 6 months period follow up |
| The patients' adherence to treatment measured by the percentage of patients withdrawn from each arm of the trial | at the end of 12 weeks study period |
| The patients' adherence to treatment measured by the percentage of missed doses in each arm of the trials | at the end of 12 weeks study period |
| 17062069 | Background | Kim MB, Ko HC, Jang HS, Oh CK, Kwon KS. Treatment of flat warts with 5% imiquimod cream. J Eur Acad Dermatol Venereol. 2006 Nov;20(10):1349-50. doi: 10.1111/j.1468-3083.2006.01709.x. No abstract available. |
| 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. |
| D006571 | Heterocyclic Compounds |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |