Clinical trial NCT05314127: Efficacy of Tazarotene in Treatment of Verruca Plana
Official title: Efficacy of Tazarotene Versus Topical 5-Fluorouracil, and Imiquimod in The Treatment of Verruca Plana
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Warts Flat
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-04-06
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
measure: The incidence of adverse events measured by the percentage of participants developing them in the four arms of the study
timeFrame: Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
Secondary outcomes:
measure: The mean percent of warts achieving PWA 0 (complete clearance) per-participant across the different arms of the clinical trial
timeFrame: Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
measure: The median time for participants to achieve clearance of all warts in the different arms of the clinical trial.
timeFrame: Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
measure: The proportion of patients achieving poor response (<50% of warts disappeared) or partial response (> 50%-99% of warts disappeared)
timeFrame: Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
measure: 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
timeFrame: at the end of 6 months period follow up
measure: The patients' adherence to treatment measured by the percentage of patients withdrawn from each arm of the trial
timeFrame: at the end of 12 weeks study period
measure: The patients' adherence to treatment measured by the percentage of missed doses in each arm of the trials
timeFrame: at the end of 12 weeks study period
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University
state: Select Region
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.