Efficacy of Tazarotene in Treatment of Verruca Plana

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

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

Study Overview

• Status: Recruiting
• Conditions: Warts Flat
• Intervention / Treatment: Drug: Tazarotene 0.1% Gel,Top; Drug: Imiquimod; Drug: Fluorouracil Cream; Drug: Petrolatum

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Select Region
    • Zagazig, Select Region, Egypt, 44511
      • Recruiting
      • Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Zagazig University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 20, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Adjuvants, Immunologic; Keratolytic Agents; Emollients; Interferon Inducers; Fluorouracil; Imiquimod; Tazarotene; Petrolatum
• Other Study ID Numbers: 9326/22-2-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes