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IRCT20221109056452N1 IRCT 2023-02-15 Tabriz University of Medical Sciences Efficacy of combined topical treatment versus cryotherapy for the treatment of refractory warts Comparison the efficacy of combined treatment of micro needling plus topical bleomycin versus cryotherapy for the treatment of hand and foot refractory warts 2023-03-06 anticipated 90 Complete https://irct.ir/trial/68589 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be using sealed envelopes, of which 90 envelopes will be selected in total and will be divided into two groups of 45, including groups A and B. Envelopes will be selected by the operating room nurse who is blind to the study groups. Group A will be the intervention group 1, group B will be the intervention group 2, Blinding description: Blinding was done for the analyzer and outcome evaluator, and the research analyst and outcome evaluator were wholly blinded to the treatment methods performed in the researched patients. 3 Hand and foot wart. Intervention 1: Intervention group 1: Micro-needle is applied to patients once every two weeks. After initial micro-needling, a bleomycin solution of 1 unit/cc is prepared and placed on the site. Micro-needling is used again to deliver bleomycin to the underlying layers, and patients are treated four times at 2-week intervals. Intervention 2: Intervention group 2: For cryotherapy, liquid nitrogen is applied for two cycles of freezing and thawing using a hand spray. The spray gun is kept perpendicular to the wart at a distance of 1 to 2 cm, and the wart is sprayed until the formation of an ice ball spreads from the center to the edge of the wart and a margin of 1 to 2 mm. Yes - There is a plan to make this available What will be shared: Study data is categorized and coded with no identifiable individuals. When: Access to study data after publication of the result is available in the journal. To whom: Anyone interested in using the data can access the study data. Conditions: Study data can be used for comparison with other results. Where to obtain: Refer to the study's scientific or public accountability person for data. How to obtain: The request will be sent by email to person responsible for scientific or public inquiries. Comments:
public Dr. Roya Vatankhah
No.23, Pasdaran allay, Shahid golestani street, Homafar1 street
Urmia Iran (Islamic Republic of) 4876345616 +98 44 3277 6395 royvtn90@gmail.com Tabriz University of Medical Sciences scientific Dr. Roya Vatankhah
No.23, Pasdaran allay, Shahid golestani street, Homafar1 street
Urmia Iran (Islamic Republic of) 4876345616 +98 44 3277 6395 royvtn90@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Treatment-resistant warts Consent to participate in the study no limit 65 years Both Pregnant and lactating women Children under four years old People over 65 years old Patients under immunosuppressive treatment Patients with immunodeficiency and hypersensitivity reactions Patients with vascular diseases Patients with Raynaud's phenomenon Patients with capillary filling more than two seconds Patients with rheumatological disorders B07.0 Plantar wart Treatment - Drugs Treatment - Other Intervention group 1: Micro-needle is applied to patients once every two weeks. After initial micro-needling, a bleomycin solution of 1 unit/cc is prepared and placed on the site. Micro-needling is used again to deliver bleomycin to the underlying layers, and patients are treated four times at 2-week intervals. Intervention group 2: For cryotherapy, liquid nitrogen is applied for two cycles of freezing and thawing using a hand spray. The spray gun is kept perpendicular to the wart at a distance of 1 to 2 cm, and the wart is sprayed until the formation of an ice ball spreads from the center to the edge of the wart and a margin of 1 to 2 mm. Effectiveness of treatment according to the physician. Timepoint: 4 and 8 weeks after intervention. Method of measurement: Physician global assessment. Effectiveness of treatment according to the patient. Timepoint: 4 and 8 weeks after intervention. Method of measurement: Patient global assessment. Local pain. Timepoint: 4 and 8 weeks after intervention. Method of measurement: Visual analogue scale. Tabriz University of Medical Sciences Approved 2023-02-06 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor, Central Building of Number 2, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)