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Efficacy of Tazarotene in Treatment of Verruca Plana

Primary Purpose

Warts Flat

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Tazarotene 0.1% Gel,Top
Imiquimod
Fluorouracil Cream
Petrolatum
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Warts Flat

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Placebo Comparator

Arm Label

Tazarotene

Imiquimod

5- fluorouracil

Petrolatum

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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
The incidence of adverse events measured by the percentage of participants developing them in the four arms of the study

Secondary Outcome Measures

The mean percent of warts achieving PWA 0 (complete clearance) per-participant across the different arms of the clinical trial
The median time for participants to achieve clearance of all warts in the different arms of the clinical trial.
The proportion of patients achieving poor response (<50% of warts disappeared) or partial response (> 50%-99% of warts disappeared)
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
The patients' adherence to treatment measured by the percentage of patients withdrawn from each arm of the trial
The patients' adherence to treatment measured by the percentage of missed doses in each arm of the trials

Full Information

First Posted
March 20, 2022
Last Updated
May 12, 2022
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05314127
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warts Flat

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tazarotene
Arm Type
Experimental
Arm Description
20 patients of verruca plana receiving daily topical Tazarotene 0.1% gel at night
Arm Title
Imiquimod
Arm Type
Active Comparator
Arm Description
20 patients with verruca plana will be treated with imiquimod cream 5% applied once daily at night
Arm Title
5- fluorouracil
Arm Type
Experimental
Arm Description
20 patients with verruca plana will be treated with topical 5- fluorouracil 5% cream applied once daily at night
Arm Title
Petrolatum
Arm Type
Placebo Comparator
Arm Description
20 patients with verruca plana will be treated with petroleum jelly once daily at night.
Intervention Type
Drug
Intervention Name(s)
Tazarotene 0.1% Gel,Top
Intervention Description
once daily topical application at night with a cotton tipped applicator on every lesion
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Intervention Description
Imiquimod cream 5% applied once daily at night with a cotton tipped applicator applied once daily.
Intervention Type
Drug
Intervention Name(s)
Fluorouracil Cream
Intervention Description
5- Fluorouracil Cream 5% is applied once daily at night with a cotton tipped applicator
Intervention Type
Drug
Intervention Name(s)
Petrolatum
Intervention Description
applied once daily at night
Primary Outcome Measure Information:
Title
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.
Description
Complete clearance is defined by complete disappearance of the warts and return to normal skin markings
Time Frame
Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
Title
The incidence of adverse events measured by the percentage of participants developing them in the four arms of the study
Time Frame
Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
Secondary Outcome Measure Information:
Title
The mean percent of warts achieving PWA 0 (complete clearance) per-participant across the different arms of the clinical trial
Time Frame
Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
Title
The median time for participants to achieve clearance of all warts in the different arms of the clinical trial.
Time Frame
Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
Title
The proportion of patients achieving poor response (<50% of warts disappeared) or partial response (> 50%-99% of warts disappeared)
Time Frame
Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
Title
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
Time Frame
at the end of 6 months period follow up
Title
The patients' adherence to treatment measured by the percentage of patients withdrawn from each arm of the trial
Time Frame
at the end of 12 weeks study period
Title
The patients' adherence to treatment measured by the percentage of missed doses in each arm of the trials
Time Frame
at the end of 12 weeks study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hagar Nofal, Dr.
Phone
01006387707
Email
hagarnofal@aucegypt.edu
Facility Information:
Facility Name
Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University
City
Zagazig
State/Province
Select Region
ZIP/Postal Code
44511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hagar Nofal, Dr.
Phone
01006387707
Email
hagarnofal@aucegypt.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
31682472
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.
Results Reference
background
PubMed Identifier
19706088
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.
Results Reference
background
PubMed Identifier
17062069
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.
Results Reference
background
PubMed Identifier
31369771
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.
Results Reference
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Efficacy of Tazarotene in Treatment of Verruca Plana

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