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IRCT20131119015455N5 IRCT 2020-02-10 Esfahan University of Medical Sciences Efficacy of TriamHexal with and without Anti-VEGF(Bevacizumab) in treatment of keloidal leisons Comparative evaluation of clinical efficacy of intra- leisonal TriamHexal with and without Anti-VEGF(Bevacizumab) in treatment of keloidal leisons 2019-10-22 anticipated 40 Complete https://irct.ir/trial/44438 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A keloidal lesion in each individual is selected randomly using simple randomization by Random Allocation Software. One group will receive intralesional Triamhexal injection and the other group (intervention group) will receive intralesional Avastin in addition to Triamhexal injection, Blinding description: This is a double blinded study in which the patient and service provider are unaware of the type of medication given to the patient. 3 Keloidal lesions. Intervention 1: Intervention group: Administration of 20 mg/dl intralesional TriamHexal (made in Germany) at weeks 0, 4, and 8 and administration of 2/5 mg/dl intralesional Avastin (made in Switzerland) (/1 cc to 1cc from vial of Avastin) at weeks 2 and 6. Intervention 2: Control group: Administration of 20 mg/dl intralesional TriamHexal (made in Germany) at weeks 0, 4, and 8. Yes - There is a plan to make this available What will be shared: Primary outcome data can be shared, if our committee approves. When: Starting 6 months after publication To whom: People working in academic institutions Conditions: Descriptive analysis is allowed to report on data Where to obtain: Bahareh Abtahi Skin Diseases and Leishmaniasis Research Center, Isfahan, Iran Email: bahareh.abtahi@med.mui.ac.ir How to obtain: The request is discussed in the Center Committee and after approval, the data is submitted to the applicant over a period of approximately one month. Comments:
public Dr. Bahareh Abtahi
Skin Diseases and Leishmaniasis Research Center, Hazrat Sedighe Tahereh Complex, Khorram Ave, Isfahan
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3335 9090 bahareh.abtahi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Zabihollah Shahmordi
Hazrat Sedighe Tahereh Complex, Khorram Ave, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3335 9090 sdlrc@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) At least 1 keloidal lesion in the trunk and extremities Age 18 to 70 years old Informed consent to participate in the study 18 years 70 years Both Pregnancy Breastfeeding History of cardiovascular diseases Unwillingness to continue treatment Not following up Patients with severe side effects Patients who have had previous keloid therapy Infection at the injection site L91.0 Hypertrophic scar Treatment - Drugs Treatment - Drugs Intervention group: Administration of 20 mg/dl intralesional TriamHexal (made in Germany) at weeks 0, 4, and 8 and administration of 2/5 mg/dl intralesional Avastin (made in Switzerland) (/1 cc to 1cc from vial of Avastin) at weeks 2 and 6. Control group: Administration of 20 mg/dl intralesional TriamHexal (made in Germany) at weeks 0, 4, and 8 Improvement rate according to physician's point of view. Timepoint: 4, 8, 12 weeks and then 3 months after intervention. Method of measurement: Vancuver score and photography assessment by two blinded dermatologists. Patient satisfaction score. Timepoint: 3 months and 6 months after intervention. Method of measurement: Visual Analogue Scale. Treatment side effects. Timepoint: 2 days after of each injection. Method of measurement: After the patient is instructed about possible side effects, the patient will be consulted by telephone to refer to the physician in case of severe side effects. Esfahan University of Medical Sciences Approved 2019-06-26 Isfahan University of Medical Sciences Research and Technology Deputy of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan Isfahan Isfehan Iran (Islamic Republic of)