Efficacy of Tazarotene in Treatment of Verruca Plana

Zagazig University

Status and phase: Unknown; Phase 2

Conditions: Warts Flat

Treatments: Drug: Tazarotene 0.1% Gel,Top; Drug: Fluorouracil Cream; Drug: Imiquimod; Drug: Petrolatum

Study type: Interventional

Funder types: Other

Identifiers

NCT05314127

9326/22-2-2022

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

Tazarotene

Experimental group

Description:

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

Treatment:

Drug: Tazarotene 0.1% Gel,Top

Imiquimod

Active Comparator group

Description:

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

Treatment:

Drug: Imiquimod

5- fluorouracil

Experimental group

Description:

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

Treatment:

Drug: Fluorouracil Cream

Petrolatum

Placebo Comparator group

Description:

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

Treatment:

Drug: Petrolatum