Efficacy of Tazarotene in Treatment of Verruca Plana

Phase 2

• Conditions: Warts Flat
• Interventions: Drug: Tazarotene 0.1% Gel,Top; Drug: Fluorouracil Cream; Drug: Petrolatum; Drug: Imiquimod

• Registration Number: NCT05314127
• Lead Sponsor: Zagazig University

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-03-20
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-06
• Study Start: 2022-04-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-16
• Primary Completion: 2022-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tazarotene	Tazarotene 0.1% Gel,Top	20 patients of verruca plana receiving daily topical Tazarotene 0.1% gel at night
5- fluorouracil	Fluorouracil Cream	20 patients with verruca plana will be treated with topical 5- fluorouracil 5% cream applied once daily at night
Petrolatum	Petrolatum	20 patients with verruca plana will be treated with petroleum jelly once daily at night.
Imiquimod	Imiquimod	20 patients with verruca plana will be treated with imiquimod cream 5% applied once daily at night

Primary Outcome Measures

Name	Time	Method
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.	Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first	Complete clearance is defined by complete disappearance of the warts and return to normal skin markings
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

Name	Time	Method
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
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 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 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 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 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

Trial Locations

Locations (1)

Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University; 🇪🇬 Zagazig, Select Region, Egypt