Efficacy of Tazarotene in Treatment of Verruca Plana

NCT ID: NCT05314127

Last Updated: 2022-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Warts Flat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tazarotene

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

Group Type EXPERIMENTAL

Tazarotene 0.1% Gel,Top

Intervention Type DRUG

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

Imiquimod

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

Group Type ACTIVE_COMPARATOR

Imiquimod

Intervention Type DRUG

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

5- fluorouracil

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

Group Type EXPERIMENTAL

Fluorouracil Cream

Intervention Type DRUG

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

Petrolatum

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

Group Type PLACEBO_COMPARATOR

Petrolatum

Intervention Type DRUG

applied once daily at night

Interventions

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Tazarotene 0.1% Gel,Top

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

Intervention Type DRUG

Imiquimod

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

Intervention Type DRUG

Fluorouracil Cream

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

Intervention Type DRUG

Petrolatum

applied once daily at night

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hagar Nofal

Lecturer, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Zagazig, Select Region, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hagar Nofal, Dr.

Role: CONTACT

01006387707

Facility Contacts

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Hagar Nofal, Dr.

Role: primary

01006387707

References

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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.

Reference Type BACKGROUND
PMID: 31682472 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19706088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17062069 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31369771 (View on PubMed)

Other Identifiers

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9326/22-2-2022

Identifier Type: -

Identifier Source: org_study_id

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