Warts FlatPhase 2NCT05314127
Efficacy of Tazarotene in Treatment of Verruca Plana
A Phase 2 study testing Tazarotene 0.1% Gel,Top, Imiquimod and Fluorouracil Cream in people with Warts Flat, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Warts Flat
- What is being tested?
- Tazarotene 0.1% Gel,Top, Imiquimod and Fluorouracil Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2022to Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Dermatology department, Zagazig University Hospitals, Faculty of Medicine, Zagazig University
Zagazig, Select Region, 44511
Hagar Nofal, Dr., 01006387707, hagarnofal@aucegypt.edu
About this study
Official title: Efficacy of Tazarotene Versus Topical 5-Fluorouracil, and Imiquimod in The Treatment of Verruca Plana
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
Read the 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.
- Conditions
- Warts Flat
- Being tested
- Tazarotene 0.1% Gel,Top, Imiquimod, Fluorouracil Cream, Petrolatum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tazarotene 0.1% Gel,TopDrug
once daily topical application at night with a cotton tipped applicator on every lesion
ImiquimodDrug
Imiquimod cream 5% applied once daily at night with a cotton tipped applicator applied once daily.
Fluorouracil CreamDrug
5- Fluorouracil Cream 5% is applied once daily at night with a cotton tipped applicator
PetrolatumDrug
applied once daily at night
| Study group | Role | What they receive |
|---|---|---|
| Tazarotene | Experimental | 20 patients of verruca plana receiving daily topical Tazarotene 0.1% gel at night Receives: 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 Receives: Drug: Imiquimod |
| 5- fluorouracil | Experimental | 20 patients with verruca plana will be treated with topical 5- fluorouracil 5% cream applied once daily at night Receives: Drug: Fluorouracil Cream |
| Petrolatum | Placebo comparator | 20 patients with verruca plana will be treated with petroleum jelly once daily at night. Receives: Drug: Petrolatum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: at the end of 12 weeks study period
The patients' adherence to treatment measured by the percentage of missed doses in each arm of the trials
Measured: at the end of 12 weeks study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start15 Apr 2022
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Warts FlatStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hagar Nofal, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314127
- Sponsor's protocol ID
- 9326/22-2-2022
- Status last verified
- May 2022
- First submitted
- 20 Mar 2022
- Last updated
- 16 May 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 31682472Gladsjo 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.
PubMed 19706088Kim 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.
PubMed 17062069Nofal 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.
PubMed 31369771
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tazarotene Versus Topical 5-Fluorouracil, and Imiquimod in The Treatment of Verruca Plana
- ClinicalTrials.gov ID
- NCT05314127
- Acronym / sponsor ID
- 9326/22-2-2022
- Conditions
- Warts Flat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tazarotene | Experimental | Drug: Tazarotene 0.1% Gel,Top20 patients of verruca plana receiving daily topical Tazarotene 0.1% gel at night |
| Imiquimod | Active comparator | Drug: Imiquimod20 patients with verruca plana will be treated with imiquimod cream 5% applied once daily at night |
| 5- fluorouracil | Experimental | Drug: Fluorouracil Cream20 patients with verruca plana will be treated with topical 5- fluorouracil 5% cream applied once daily at night |
| Petrolatum | Placebo comparator | Drug: Petrolatum20 patients with verruca plana will be treated with petroleum jelly once daily at night. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- All participants must be willing to sign informed consent; for patients younger than 18 years old, parents or guardians will sign an informed consent
Key exclusion criteria (6 listed)
- • History of hypersensitivity to any of the drugs used.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tazarotene 0.1% Gel,Toponce daily topical application at night with a cotton tipped applicator on every lesion | Drug | Tazarotene |
| ImiquimodImiquimod cream 5% applied once daily at night with a cotton tipped applicator applied once daily. | Drug | Imiquimod |
| Fluorouracil Cream5- Fluorouracil Cream 5% is applied once daily at night with a cotton tipped applicator | Drug | 5- fluorouracil |
| Petrolatumapplied once daily at night | Drug | Petrolatum |
Primary outcome
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.
Time frame: Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
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
Time frame: Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Background: PubMed 31682472Hodeib 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.
- Background: PubMed 19706088Gladsjo 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.
- Background: PubMed 17062069Kim 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.
- Background: PubMed 31369771Nofal 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tazarotene 0.1% Gel,Top, Imiquimod and Fluorouracil Cream in people with Warts Flat, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hagar Nofal, Dr. (01006387707, hagarnofal@aucegypt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Till complete clearance of all lesions or a maximum of 12 weeks, whichever came first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05314127, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.