Efficacy of Tazarotene in Treatment of Verruca Plana

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Efficacy of Tazarotene Versus Topical 5-Fluorouracil, and Imiquimod in The Treatment of Verruca Plana

Conditions
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Warts Flat

Intervention / Treatment
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* Drug: Tazarotene 0.1% Gel,Top
* Drug: Imiquimod
* Drug: Fluorouracil Cream
* Drug: Petrolatum


Participation Criteria
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Eligibility Criteria
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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 Age > 4 years. Both sexes. Patients with clinically and dermoscopically diagnosed plane warts. Subject is willing and able to follow all study instructions and to attend all study visits Exclusion Criteria: • History of hypersensitivity to any of the drugs used. Pregnancy and lactation. Patients with epidermodysplasia verruciformis syndrome. Patients with eczematous skin disorders. Presence of any active infections e.g. herpes, tuberculosis. History of topical anti wart treatment within 4 weeks of recruitment to the study, and a 12-week period for systemic anti-wart treatment, or immunotherapy, or HPV vaccine in the last 24 weeks.

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tazarotene<br>20 patients of verruca plana receiving daily topical Tazarotene 0.1% gel at night | Drug: Tazarotene 0.1% Gel,Top<br>* once daily topical application at night with a cotton tipped applicator on every lesion<br>|
| Active Comparator: Imiquimod<br>20 patients with verruca plana will be treated with imiquimod cream 5% applied once daily at night | Drug: Imiquimod<br>* Imiquimod cream 5% applied once daily at night with a cotton tipped applicator applied once daily.<br>|
| Experimental: 5- fluorouracil<br>20 patients with verruca plana will be treated with topical 5- fluorouracil 5% cream applied once daily at night | Drug: Fluorouracil Cream<br>* 5- Fluorouracil Cream 5% is applied once daily at night with a cotton tipped applicator<br>|
| Placebo Comparator: Petrolatum<br>20 patients with verruca plana will be treated with petroleum jelly once daily at night. | Drug: Petrolatum<br>* applied once daily at night<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 |