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

Evaluation of the efficacy and side effects of botulinum toxin type A injection with cross linked hyaluronic acid in comparison with non cross linked hyaluronic acid in the treatment of icepick acne scar

Clinical trial with two intervention groups, parallel, double-blind, randomized, phase 3 on 16 patients, randomized with sealed envelopes

For injection, botulinum toxin type A is diluted with normal saline and then, depending on the extent of the scar and the area being treated, each volume of Dysport is drawn into a 1 cc syringe, five times mixed and diluted with hyaluronic acid (cross linked or non cross linked). The patient does not know in which treatment group he is. The data are also evaluated by the patient himself and a blind dermatologist and finally the statistical specialist, who also does not know which drug combination was injected in each group, analyzes the results of the study.

Inclusion criteria: Patients with icepick acne scars in the range of 18 to 40 years Exclusion criteria: active acne, inflammation or active infection of herpes at the procedure site, hemodynamic instability, taking anticoagulant or NSAID during the previous 48 hours and also patients with platelet dysfunction or thrombocytopenia, serious internal disease, comorbidity at the treatment site

Group 1: Injection of botulinum toxin type A and cross linked hyaluronic acid, Group 2: Injection of botulinum toxin type A and non cross linked hyaluronic acid

Qualitative and quantitative severity of scar with Visioface, The rate of improvement with Global Aesthetic Improvement Scale (GAIS)

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.

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.