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 * Group (A): Patients will be treated with topical tazarotene gel 0.1%with a cotton tipped applicator on every lesion once daily at night. * Group (B): Patients will be treated with topical 5- fluorouracil 5% cream applied once daily at night. * Group (C): Patients will be treated with imiquimod cream 5% applied once daily at night. * Group (D): Patients will be treated with petroleum jelly once daily at night.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
once daily topical application at night with a cotton tipped applicator on every lesion
Imiquimod cream 5% applied once daily at night with a cotton tipped applicator applied once daily.
5- Fluorouracil Cream 5% is applied once daily at night with a cotton tipped applicator
applied once daily at night
Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University
Zagazig, Select Region, Egypt
RECRUITINGThe 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
Time frame: 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
Time frame: Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
The mean percent of warts achieving PWA 0 (complete clearance) per-participant across the different arms of the clinical trial
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at the end of 12 weeks study period
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