About this trial
To compare between the efficacy and safety of microneedling alone, microneedling with topical bleomycin and microneedling with 5-flurouracil in treatment of planter warts.
Microneedling will be performed on each wart using dermapen supplied with 12 needles arranged in rows. Topical anesthetic cream will be applied for 60 min before the procedures. Microneedling will be performed on each wart using dermapen. The penetration depth will be adjusted at 2-mm, endpoint is pinpoint bleeding and the dermapen will be held by the hand in a vertical direction on the warts.
Bleomycin is typically supplied in 15 U vials. The preparation will be diluted first with 7 mL normal saline ,double the amount taken from the vial by adding the same amount lidocaine (2%), so that the concentrations become 1 U/mL . The maximum total amount of bleomycin taken to each patient in one session will be 1 U/1 mL . Microneedling will be performed on the lesion using a microneedling pen type device with a 1-cm tip diameter at a 2-mm depth setting for 2-3 minutes until pinpoint bleebing occurs 1 mL of the prepared solution of bleomycin (1 U/1 mL) will be dropped on to the wart tissue using insulin syringe and occlusion will be applied for 3 hours.
5-FU is available in 10 mL vial: 500 mg/10 mL. Application of 5-FU solution will be done by dropping using an insulin syringe (1 mL)to help dropping of the solution on the warts surface. Then, the lesion will be occluded with a plaster for 3 h.
Sessions: Sessions will be performed every 2 weeks until complete cure or for maximum 6 sessions (total 3 month)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Bleomycin
Drug);will be treated with combination of microneedling and topical bleomycin .
Microneedling alone
Device' Microneedling will be performed on each wart using dermapen supplied with 12 needles arranged in rows. Topical anesthetic cream will be applied for 60 min before the procedures. Microneedling will be performed on each wart using dermapen. The penetration depth will be adjusted at 2-mm, endpoint is pinpoint bleeding and the dermapen will be held by the hand in a vertical direction on the warts.
5 fluorouracil
Drug);will be treated with combination of microneedling and topical 5-flurouracil .
Treatment groups
Trial outcomes
Primary outcomes
The primary outcome is the clinical response, specifically the decrease in the size of warts as measured by a ruler.
The response is categorized as: Complete response: Disappearance of the wart and return of normal skin markings. Partial response: 50% to 99% reduction in wart size. No or minimal response: 0% to 49% decrease in wart size
Secondary outcomes
Recurrence rate
The appearance of new wart lesions at the treated sites after complete remission during the three-month follow-up period is recorded as recurrence
Locations
Sponsors and contacts
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