A Phase 4 interventional study of Topical tretinoin 0.05% and Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day) in Plane Warts, sponsored by Tishreen University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Tishreen University · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Patients apply tretinoin cream 0.05% once daily at night for 3 months
Drug: Topical tretinoin 0.05%
Patients apply tretinoin cream 0.05% and receive oral isotretinoin capsule in the dose of 0.5 mg/kg/day for 3 months
Drug: Topical tretinoin 0.05% + oral isotretinoin (0.5 mg/kg/day)
Topical tretinoin cream 0.05% applied once daily at night
Topical tretinoin cream 0.05% once daily at night + oral isotretinoin capsule in the dose of 0.5 mg/kg/day
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).
Time frame: 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).
Time frame: 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).
Time frame: Week 12
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
Time frame: 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
Time frame: 12 weeks after termination of therapy
Plan to share: Yes — Individual participant data that underlie the results of this study after deidentification
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Tishreen University