skin rejuvenation.
Conditions
Interventions
Intervention 1: Intervention group: botulinum toxin type A (product of Imen Vaccine Alborz CO) 500iu vial, intra muscular injection, 40-60iu in 2.5 cc normal saline in 3 point in frontal area in one v
Sponsors
Espad pharmed Company
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Men and women with 18 to 65 years old Mild to moderate Glabellar Lines Signing informed consent form
Exclusion criteria
Exclusion criteria: Previous treatment in the glabellar area within 12 months prior to randomization History of facial plastic surgery, eyebrow lift and dermal resurfacing History of inserting non-absorbent substances or surgery to remove the glabellar muscle. Severe atrophy in glabellar area Planned Facial Cosmetic Surgery (such as filler injection, chemical peeling and laser) Using products that cause skin remodeling or active changes on the forehead area and History of any cosmetic surgery in glabellar area in the last 6 months Active infection in injection area Facial expressions that can impair safety or efficacy outcomes. Neuromuscular connectivity disorders Current treatment with drugs that interfere with neuromuscular function. Allergies to botulinum neurotoxin as well as injectable fillers in the facial area Participate in another research study on botulinum neurotoxin products and fillers in the last 6 months Any other condition that may expose a risk to the volunteer during the study or disrupt safety or efficacy outcomes Pregnancy/ breast feeding History of eyebrow tattoo or any other procedure in the eyebrow area during the last month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with improvement in Glabellar Lines at maximum frown. Timepoint: 30 days after intervention. Method of measurement: GLSS (Glabellar Lines Severity Score). | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with improvement in Glabellar Lines at resting. Timepoint: Before intervention, 14, 30, 90 and 120 days later. Method of measurement: GLSS.;Percentage of subjects with improvement in Glabellar Lines at maximum frown using SSA scoring. Timepoint: Before intervention, 14, 30, 90 and 120 days later. Method of measurement: Subject Self Assessment (SSA).;Percentage of subjects with improvement in Glabellar Lines at rest using SSA scoring. Timepoint: Before intervention, 14, 30, 90 and 120 days later. Method of measurement: Subject Self-Assessment (SSA).;Percentage of subjects with improvement in Glabellar Lines at maximum frown. Timepoint: on days 14, 90 and 120 after receiving treatment. Method of measurement: GLSS (Glabellar Lines Severity Score).;Received accumulative dose (total dose received at visit 1 and touch-up visit). Timepoint: 14 days after intervention. Method of measurement: Calculation of total dose received at visit 1 and touch-up visit).;Onset of action at rest. Timepoint: 14 days after intervention. Method of measurement: Subject Self-Assessment (SSA).;Onset of action at maximum frown. Timepoint: 14 days after intervention. Method of measurement: Subject Self-Assessment (SSA).;Assessment of the occurrence of adverse events. Timepoint: On days 14, 90 and 120 after receiving treatment. Method of measurement: All adverse events including related and unrelated adverse events, serious (such as dysphagia, muscle weakness and allergic reactions) and non-serious events will be recorded and reported. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAniseh Samadi
Tehran University of Medical Sciences
Outcome results
None listed