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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Patients apply tretinoin cream 0.05% once daily at night for 3 months |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical tretinoin 0.05% | Drug | Topical tretinoin cream 0.05% applied once daily at night |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | week 12 |
| Recurrence Rate, as Measured by the Number of Patients who Have Recurrent Lesions After 12 Weeks of Termination of Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeina M Habib, MD | Tishreen University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tishreen University- Faculty of Medicine | Latakia | Latakia Governorate | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| Background | 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. | ||
| Background | Nooruldeen AD, Saeed MY: Efficacy and safety of oral isotretinoin in treatment of plane warts. Bali Med J. 2021, 10(3): 1076-7080 | ||
| 39712939 | Background | 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. |
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Individual participant data that underlie the results of this study after deidentification
Beginning 2 months and ending 5 months following publication
researchers who provide a methodological proposal
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| ID | Term |
|---|---|
| D014212 | Tretinoin |
| D015474 | Isotretinoin |
| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 |
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| 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 |
|
The recurrence is defined as reappearance of lesions at the same locations after complete response |
| 12 weeks after termination of therapy |
| 28901534 | Background | Kaur 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. |
| 25273231 | Background | Sterling 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. |
| Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |