Plane WartsPhase 4NCT07012811
Treatment of Plane Warts With Topical and Oral Retinoids
A Phase 4 study testing Topical tretinoin 0.05% and Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day) in people with Plane Warts, run by Latakia University at 1 site in Syria.
Trial summary
The aim of this study was to compare the effectiveness and safety of topical tretinoin cream 0.05% alone against combination with oral isotretinoin (0.5 mg/kg/day) for treatment of plane warts. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Plane Warts
- What is being tested?
- Topical tretinoin 0.05% and Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSyria
- Study dates
- 12 Feb 2024to 30 Mar 2025
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients above 12 years diagnosed with plane warts.
- Patients who had not received any treatment for warts in the last month.
Who cannot join
- Pregnancy and lactation.
- Abnormal lipid profile.
- Significant hepatic or renal dysfunction.
- Depression.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Tishreen University- Faculty of Medicine
Latakia, Latakia Governorate
About this study
Official title: Evaluation of Topical Tretinoin 0.05% Alone Versus Combination With Oral Isotretinoin (0.5 mg/kg/Day) in the Treatment of Plane Warts
The aim of this study was to compare the effectiveness and safety of topical tretinoin cream 0.05% alone against combination with oral isotretinoin (0.5 mg/kg/day) for treatment of plane warts.
Read the detailed description
This study included 39 patients divided into two groups. Treatment was given for three months duration. Patients were followed-up for further three months to assess the recurrence rate. Combination treatment led to a faster resolution and a higher percentage of complete response. It presents a promising effective alternative option for treatment of plane warts.
- Conditions
- Plane Warts
- Being tested
- Topical tretinoin 0.05%, Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day)
- Keywords
- Human papillomavirus, Tretinoin, Isotretinoin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical tretinoin 0.05%Drug
Topical tretinoin cream 0.05% applied once daily at night
Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day)Drug
Topical tretinoin cream 0.05% once daily at night + oral isotretinoin capsule in the dose of 0.5 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients apply tretinoin cream 0.05% once daily at night for 3 months Receives: Drug: Topical tretinoin 0.05% |
| Group B | Experimental | Patients apply tretinoin cream 0.05% and receive oral isotretinoin capsule in the dose of 0.5 mg/kg/day for 3 months Receives: Drug: Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate, as Measured by the Reduction in Number of Lesions at Week 4
The response is assessed according to the decrease in number of lesions as followed: complete response (total clearance of warts), partial response (decease in the number of lesion ≥ 50%), no response (decrease in the number of lesion <50% or no clearance).
Measured: Week 4
Response Rate, as Measured by the Reduction in Number of Lesions at Week 8
The response is assessed according to the decrease in number of lesions as followed: complete response (total clearance of warts), partial response (decease in the number of lesion ≥ 50%), no response (decrease in the number of lesion <50% or no clearance).
Measured: Week 8
Response Rate, as Measured by the Reduction in Number of Lesions at Week 12
The response is assessed according to the decrease in number of lesions as followed: complete response (total clearance of warts), partial response (decease in the number of lesion ≥ 50%), no response (decrease in the number of lesion <50% or no clearance).
Measured: Week 12
Secondary outcomes (2)
Safety, as Measured by the Number of Patients With at Least one Adverse Effect
The adverse effects are defined as unwanted effects related directly to the drug
Measured: week 12
Recurrence Rate, as Measured by the Number of Patients who Have Recurrent Lesions After 12 Weeks of Termination of Therapy
The recurrence is defined as reappearance of lesions at the same locations after complete response
Measured: 12 weeks after termination of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start12 Feb 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Plane WartsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeina M Habib, MD, Principal investigator, Tishreen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012811
- Sponsor's protocol ID
- TishreenU - Plane Warts
- Status last verified
- Jun 2025
- First submitted
- 29 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results of this study after deidentification
Publications
Singh R, Pandey SS: Efficacy of topical 5% 5-fluorouracil and 0.05% tretinoin and electrosurgery in the treatment of plane warts: a randomized controlled comparative trial. Nepal J Dermatol Venereol & Leprol. 2021, 19(1):55-9
Randhawa NK, Kumar S, Agarwal US, Agarwal P, Bansal A, Meena S: To evaluate efficacy and safety of low dose oral isotretinoin (20 mg/day) alone versus combination of low dose oral isotretinoin (20 mg/day) plus topical tretinoin (0.1%) in gel formulation in the treatment of verruca plana. J Clin Exp Dermatol Res. 2023, 14:635.
Nooruldeen AD, Saeed MY: Efficacy and safety of oral isotretinoin in treatment of plane warts. Bali Med J. 2021, 10(3): 1076-7080
Dong ZY, He MJ, Hu Y, Wang F, Ran DL, Fu DS, He Q, Yang RP, Zhang JA. Unveiling the Mechanism of Retinoic Acid Therapy for Cutaneous Warts: Insights from Multi-Omics Integration. Clin Cosmet Investig Dermatol. 2024 Dec 18;17:2923-2932. doi: 10.2147/CCID.S504391. eCollection 2024.
PubMed 39712939Kaur GJ, Brar BK, Kumar S, Brar SK, Singh B. Evaluation of the efficacy and safety of oral isotretinoin versus topical isotretinoin in the treatment of plane warts: a randomized open trial. Int J Dermatol. 2017 Dec;56(12):1352-1358. doi: 10.1111/ijd.13727. Epub 2017 Sep 13.
PubMed 28901534Sterling JC, Gibbs S, Haque Hussain SS, Mohd Mustapa MF, Handfield-Jones SE. British Association of Dermatologists' guidelines for the management of cutaneous warts 2014. Br J Dermatol. 2014 Oct;171(4):696-712. doi: 10.1111/bjd.13310. Epub 2014 Oct 1. No abstract available.
PubMed 25273231
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Tretinoin 0.05% Alone Versus Combination With Oral Isotretinoin (0.5 mg/kg/Day) in the Treatment of Plane Warts
- ClinicalTrials.gov ID
- NCT07012811
- Acronym / sponsor ID
- TishreenU - Plane Warts
- Conditions
- Plane Warts
- Keywords
- Human papillomavirus, Tretinoin, Isotretinoin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 10 Jun 2025 (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.
The aim of this study was to compare the effectiveness and safety of topical tretinoin cream 0.05% alone against combination with oral isotretinoin (0.5 mg/kg/day) for treatment of plane warts.
Detailed description
This study included 39 patients divided into two groups. Treatment was given for three months duration. Patients were followed-up for further three months to assess the recurrence rate. Combination treatment led to a faster resolution and a higher percentage of complete response. It presents a promising effective alternative option for treatment of plane warts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Topical tretinoin 0.05%Patients apply tretinoin cream 0.05% once daily at night for 3 months |
| Group B | Experimental | Drug: Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day)Patients apply tretinoin cream 0.05% and receive oral isotretinoin capsule in the dose of 0.5 mg/kg/day for 3 months |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients above 12 years diagnosed with plane warts.
- Patients who had not received any treatment for warts in the last month.
Key exclusion criteria (4 listed)
- Pregnancy and lactation.
- Abnormal lipid profile.
- Significant hepatic or renal dysfunction.
- Depression.
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 |
|---|---|---|
| Topical tretinoin 0.05%Topical tretinoin cream 0.05% applied once daily at night | Drug | Group A |
| Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day)Topical tretinoin cream 0.05% once daily at night + oral isotretinoin capsule in the dose of 0.5 mg/kg/day | Drug | Group B |
Primary outcome
Response Rate, as Measured by the Reduction in Number of Lesions at Week 4
Time frame: Week 4
The response is assessed according to the decrease in number of lesions as followed: complete response (total clearance of warts), partial response (decease in the number of lesion ≥ 50%), no response (decrease in the number of lesion <50% or no clearance).
Response Rate, as Measured by the Reduction in Number of Lesions at Week 8
Time frame: Week 8
The response is assessed according to the decrease in number of lesions as followed: complete response (total clearance of warts), partial response (decease in the number of lesion ≥ 50%), no response (decrease in the number of lesion <50% or no clearance).
Response Rate, as Measured by the Reduction in Number of Lesions at Week 12
Time frame: Week 12
The response is assessed according to the decrease in number of lesions as followed: complete response (total clearance of warts), partial response (decease in the number of lesion ≥ 50%), no response (decrease in the number of lesion <50% or no clearance).
2 secondary outcomes
Safety, as Measured by the Number of Patients With at Least one Adverse Effect
Time frame: week 12
Recurrence Rate, as Measured by the Number of Patients who Have Recurrent Lesions After 12 Weeks of Termination of Therapy
Time frame: 12 weeks after termination of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- BackgroundSingh R, Pandey SS: Efficacy of topical 5% 5-fluorouracil and 0.05% tretinoin and electrosurgery in the treatment of plane warts: a randomized controlled comparative trial. Nepal J Dermatol Venereol & Leprol. 2021, 19(1):55-9
- BackgroundRandhawa NK, Kumar S, Agarwal US, Agarwal P, Bansal A, Meena S: To evaluate efficacy and safety of low dose oral isotretinoin (20 mg/day) alone versus combination of low dose oral isotretinoin (20 mg/day) plus topical tretinoin (0.1%) in gel formulation in the treatment of verruca plana. J Clin Exp Dermatol Res. 2023, 14:635.
- BackgroundNooruldeen AD, Saeed MY: Efficacy and safety of oral isotretinoin in treatment of plane warts. Bali Med J. 2021, 10(3): 1076-7080
- Background: PubMed 39712939Dong ZY, He MJ, Hu Y, Wang F, Ran DL, Fu DS, He Q, Yang RP, Zhang JA. Unveiling the Mechanism of Retinoic Acid Therapy for Cutaneous Warts: Insights from Multi-Omics Integration. Clin Cosmet Investig Dermatol. 2024 Dec 18;17:2923-2932. doi: 10.2147/CCID.S504391. eCollection 2024.
- Background: PubMed 28901534Kaur GJ, Brar BK, Kumar S, Brar SK, Singh B. Evaluation of the efficacy and safety of oral isotretinoin versus topical isotretinoin in the treatment of plane warts: a randomized open trial. Int J Dermatol. 2017 Dec;56(12):1352-1358. doi: 10.1111/ijd.13727. Epub 2017 Sep 13.
- Background: PubMed 25273231Sterling JC, Gibbs S, Haque Hussain SS, Mohd Mustapa MF, Handfield-Jones SE. British Association of Dermatologists' guidelines for the management of cutaneous warts 2014. Br J Dermatol. 2014 Oct;171(4):696-712. doi: 10.1111/bjd.13310. Epub 2014 Oct 1. No abstract available.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results of this study after deidentification
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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.
Zeina M Habib, MD principal investigator
Tishreen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical tretinoin 0.05% and Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day) in people with Plane Warts, run by Latakia University at 1 site in Syria.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 10 Jun 2025. 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 Syria. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate, as Measured by the Reduction in Number of Lesions at Week 4 (time frame: Week 4). The study lists 3 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 NCT07012811, which also lists 6 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 10 Jun 2025.