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IRCT20241113063694N1 IRCT 2024-11-17 Tehran University of Medical Sciences Comparison of the effectiveness of high-dose and low-dose Hyaluronidase in the treatment of patients with vascular complications after hyaluronic acid filler injection Comparison of the effectiveness of high-dose and low-dose hyaluronidase in the treatment of patients with vascular complications after hyaluronic acid filler injection 2024-11-20 anticipated 30 Complete https://irct.ir/trial/80165 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to two groups of high and low-dose Hyaluronidase through the block randomization method. A trained research assistant uses this method for randomization. Block size will be equal to 4 with equal probability to assign patients in each group (high dose group (group B) and low dose (group A). According to the size of the blocks, we have six possible permutations including AABB, ABAB, BAAB , we will have BABA, BBAA, and ABBA.At first, the assistant will randomly select one of these blocks, and four eligible patients will be determined based on that in each block. We will repeat this process many times Eligible patients are included in the study, Blinding description: Although patients will be informed of our primary goals, they will not know which drug they will receive. Due to the difference in the dose injected to the patients, it is not possible to blind the resident who is responsible for injecting the drug. The final evaluation is done by a skin and hair disease specialist using the clinical evaluation of the appearance of the lesion and the patient's symptoms. It should be mentioned that the final evaluator does not know the injected doses for each patient. 3 Patients who suffered vascular complications following hyaluronic acid filler injection. Intervention 1: Intervention group: To the patients who are placed in the hyaluronidase group with a high dose ,1500 units of hyaluronidase will inject with a needle, two hours later another 1500 units will inject. Intervention 2: Control group: In the low dose group, 300 units of hyaluronidase will injected in the necrotic areas, and two hours later, 300 units will injected again. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hamidreza Mahmoudi
Tehran-Vahdat-Islami St.-Vahdat-Islami Square-Razi Dead End-Razi Skin Specialist Hospital
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5288 8282 hr_mahmoody@yahoo.com Tehran University of Medical Sciences scientific Hamidreza Mahmoudi
Tehran-Vahdat-Islami St., Vahdat-Islami Square-Razi Dead End-Razi Skin Specialist Hospital
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5288 8282 hr_mahmoody@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Vascular complication following hyaluronic acid filler injection in the face area Occurrence of symptoms related to vascular complications (such as blanching, severe and sudden pain, Livedo reticularis, prolongation of capillary filling, ischemia and necrosis) 18 years 70 years Both Injection of fillers other than hyaluronic acid Injection in areas other than the face The patient's sensitivity to hyaluronidase Hyaluronidase injection before going to the hospital Patient dissatisfaction The patient's need for additional treatments compared to research Treatment - Drugs Treatment - Drugs Intervention group: To the patients who are placed in the hyaluronidase group with a high dose ,1500 units of hyaluronidase will inject with a needle, two hours later another 1500 units will inject. Control group: In the low dose group, 300 units of hyaluronidase will injected in the necrotic areas, and two hours later, 300 units will injected again. Any skin effects that remain from the initial lesion, such as scars, hypopigmentation, hyperpigmentation. Timepoint: Follow-up of patients in both groups is evaluated at 24 hours, 48 ​​hours, one week, one month, and three months after the injection. Method of measurement: The clinical outcome is considered as Favorable outcome, Borderline outcome, Unfavorable outcome. Favorable outcome is the complete healing of the lesion and wound without leaving any scars or hypohyperpigmentation. Borderline outcome includes the complete healing of the lesion without leaving a scar with hypohyperpigmentation and Unfavorable outcome is the formation of a scar regardless of other symptoms. Tehran University of Medical Sciences Approved 2024-05-29 Ethics committee of Tehran University of Medical Sciences Keshavarz Blvd., intersection of Qods St., Central Building of Tehran University of Medical Sciences, sixth floor, room 604 Tehran Tehran Iran (Islamic Republic of)