Efficacy of Tazarotene in Treatment of Verruca Plana

NCT05314127 | Unknown Phase 2 FDA Drug

• 1 other identifier: 9326/22-2-2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Warts Flat

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (4)

Tazarotene

EXPERIMENTAL

20 patients of verruca plana receiving daily topical Tazarotene 0.1% gel at night

Drug: Tazarotene 0.1% Gel,Top

Imiquimod

ACTIVE COMPARATOR

20 patients with verruca plana will be treated with imiquimod cream 5% applied once daily at night

Drug: Imiquimod

5- fluorouracil

EXPERIMENTAL

20 patients with verruca plana will be treated with topical 5- fluorouracil 5% cream applied once daily at night

Drug: Fluorouracil Cream

Petrolatum

PLACEBO COMPARATOR

20 patients with verruca plana will be treated with petroleum jelly once daily at night.

Drug: Petrolatum

Interventions

Tazarotene 0.1% Gel,Top DRUG

once daily topical application at night with a cotton tipped applicator on every lesion

Tazarotene

Imiquimod DRUG

Imiquimod cream 5% applied once daily at night with a cotton tipped applicator applied once daily.

Imiquimod

Fluorouracil Cream DRUG

5- Fluorouracil Cream 5% is applied once daily at night with a cotton tipped applicator

5- fluorouracil

Petrolatum DRUG

applied once daily at night

Petrolatum

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University

Zagazig, Select Region, 44511, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 31682472 BACKGROUND

• 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.

  PMID: 19706088 BACKGROUND

• 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.

  PMID: 17062069 BACKGROUND

• 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.

  PMID: 31369771 BACKGROUND

MeSH Terms

Interventions

tazarotene; Imiquimod; Petrolatum

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hydrocarbons; Organic Chemicals

Central Study Contacts

Hagar Nofal, Dr.

CONTACT

01006387707; hagarnofal@aucegypt.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Principal Investigator

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: April 6, 2022
• Study Start: April 15, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

EG (1)