Plane Warts
Conditions
Keywords
Human papillomavirus, Tretinoin, Isotretinoin
Brief 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.
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.
Interventions
DRUGTopical tretinoin 0.05%
Topical tretinoin cream 0.05% applied once daily at night
DRUGTopical 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
Sponsors
Tishreen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients above 12 years diagnosed with plane warts. * Patients who had not received any treatment for warts in the last month.
Exclusion criteria
* Pregnancy and lactation. * Abnormal lipid profile. * Significant hepatic or renal dysfunction. * Depression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate, as Measured by the Reduction in Number of Lesions at Week 4 | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety, as Measured by the Number of Patients With at Least one Adverse Effect | week 12 | The adverse effects are defined as unwanted effects related directly to the drug |
| Recurrence Rate, as Measured by the Number of Patients who Have Recurrent Lesions After 12 Weeks of Termination of Therapy | 12 weeks after termination of therapy | The recurrence is defined as reappearance of lesions at the same locations after complete response |
Countries
Syria
Outcome results
None listed