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IRCT20210718051930N1 IRCT 2021-07-30 Iran University of Medical Sciences Comparison of the effect of combining botulinum toxin and cross-linked hyaluronic acid with non cross-linked hyaluronic acid in the treatment of icepick acne scar Evaluation of the efficacy and safety of botulinum toxin type A injection with cross-linked hyaluronic acid in comparison with non cross-linked hyaluronic acid in the treatment of patients with icepick acne scar: A double blind controlled randomized clinical trial 2021-09-06 anticipated 16 Complete https://irct.ir/trial/57609 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After being selected by available method, patients are divided into two groups by simple randomization, so that among 16 sealed bags, one bag will be randomly selected for each patient. Each bag contains the letter a or b: a for the group receiving botulinum toxin type A and cross-linked hyaluronic acid and b for the group receiving botulinum toxin type A and non cross-linked hyaluronic acid, Blinding description: For group a patients, a combination of botulinum toxin type A and cross-linked hyaluronic acid is injected once, and for group b patients, a combination of botulinum toxin type A and non cross-linked hyaluronic acid is injected twice with a month interval. The patient does not know in which treatment group he is. In order to evaluate, in two groups, before treatment, 1 month later and then 3 and 6 months after one month follow-up, the severity of icepick scars is measured qualitatively and quantitatively by Visioface and also the rate of improvement with Global Aesthetic Improvement Scale (GAIS) is determined by the patient and a blind dermatologist. Finally, the statistician, who also does not know which drug combination was injected in each group, analyzes the results of the study. 3 icepick acne scar patients. Intervention 1: Intervention group 1: For patients in this group, a combination of botulinum toxin type A and cross-linked hyaluronic acid is injected once. For injection, botulinum toxin type A: Dysport® (abobotulinumtoxinA) with 300 units/vial is dissolved with 2 cc of normal saline and then, depending on the extent of the scar and the treated area, each volume of Dysport is drawn in the BD lower lock syringe, is mixed and diluted five times with cross-link hyaluronic acid through the interface 30 times. So that each small line of BD syringe contains 0.6 units of Dysport (microbotax). Cross-link hyaluronic acid used has low G prime of the NEAUVIA 22mg or INTENCE / REOLOGY brand. This injection is performed after local anesthesia with XylaP cream for 45 minutes and then wiping it with an alcohol swab, with Gauge 27 mesotherapy needle and under the scars intradermally. Intervention 2: Intervention group 2: For patients in this group, a combination of botulinum toxin type A and non cross-linked hyaluronic acid is injected twice with 1 month interval. For injection, botulinum toxin type A: Dysport® (abobotulinumtoxinA) with 300 units/vial is dissolved with 2 cc of normal saline and then, depending on the extent of the scar and the treated area, each volume of Dysport is drawn in the BD lower lock syringe, is mixed and diluted five times with non cross-link hyaluronic acid through the interface 30 times. So that each small line of BD syringe contains 0.6 units of Dysport (microbotax). Non cross-link hyaluronic acid used has REVITACARE 532 CYTOCARE brand. This injection is performed after local anesthesia with XylaP cream for 45 minutes and then wiping it with an alcohol swab, with Gauge 30 mesotherapy needle and under the scars intradermally. 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 more information.
public Elham Behrangi
Dermatology ward, Hazrat Rasool Akram hospital, Niayesh avenue, Satarkhan street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 7341 elham.behrangi@gmail.com Iran University of Medical Sciences scientific Elham Behrangi
Dermatology ward, Hazrat Rasool Akram hospital, Niayesh avenue, Satarkhan street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 7341 elham.behrangi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) All patients with icepick acne scar in the range of 18 to 40 years Having informed consent to participate in the study Possibility to attend visit and follow-up sections 18 years 40 years Both Active acne Inflammation or herpes simplex virus infection at the site of the procedure Taking anticoagulants or NSAIDs within 48 hours before and in patients with platelet dysfunction or thrombocytopenia Serious internal disease Accompanying disease at the treatment site L70.0 Acne vulgaris Treatment - Drugs Treatment - Drugs Intervention group 1: For patients in this group, a combination of botulinum toxin type A and cross-linked hyaluronic acid is injected once. For injection, botulinum toxin type A: Dysport® (abobotulinumtoxinA) with 300 units/vial is dissolved with 2 cc of normal saline and then, depending on the extent of the scar and the treated area, each volume of Dysport is drawn in the BD lower lock syringe, is mixed and diluted five times with cross-link hyaluronic acid through the interface 30 times. So that each small line of BD syringe contains 0.6 units of Dysport (microbotax). Cross-link hyaluronic acid used has low G prime of the NEAUVIA 22mg or INTENCE / REOLOGY brand. This injection is performed after local anesthesia with XylaP cream for 45 minutes and then wiping it with an alcohol swab, with Gauge 27 mesotherapy needle and under the scars intradermally. Intervention group 2: For patients in this group, a combination of botulinum toxin type A and non cross-linked hyaluronic acid is injected twice with 1 month interval. For injection, botulinum toxin type A: Dysport® (abobotulinumtoxinA) with 300 units/vial is dissolved with 2 cc of normal saline and then, depending on the extent of the scar and the treated area, each volume of Dysport is drawn in the BD lower lock syringe, is mixed and diluted five times with non cross-link hyaluronic acid through the interface 30 times. So that each small line of BD syringe contains 0.6 units of Dysport (microbotax). Non cross-link hyaluronic acid used has REVITACARE 532 CYTOCARE brand. This injection is performed after local anesthesia with XylaP cream for 45 minutes and then wiping it with an alcohol swab, with Gauge 30 mesotherapy needle and under the scars intradermally. Qualitative intensity of scar. Timepoint: At the beginning of the study, 1 month later and then 3 and 6 months later. Method of measurement: Photography with Visioface. Quantitative intensity of scar. Timepoint: At the beginning of the study, 1 month later and then 3 and 6 months later. Method of measurement: Determine the depth of the scar by photography with Visioface. The rate of improvement in scar. Timepoint: 1 month after starting treatment and then 3 and 6 months later. Method of measurement: according to Global Aesthetic Improvement Scale (GAIS). Side effects. Timepoint: 1 month after starting treatment and then 3 and 6 months later. Method of measurement: Clinical evaluation. Iran University of Medical Sciences Approved 2021-07-03 Ethics committee of Iran University of medical scinces Hazrat Rasool Akram hospital, Mansoori avenue, Sattarkhan street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)