Frowning line.
Conditions
Interventions
Intervention group: First, a vial containing 500 units of abobotulinum toxin type A manufactured by Ronac Pharmaceutical Company is mixed with 2.5 ml of sodium chloride injection 0.9% and mixed slowly
Sponsors
Ronak Pharmaceutical Co.
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Suffering from moderate to severe frown lines in the state of maximum frown area according to the GLSS criterion 18 to 65 years old Having informed consent
Exclusion criteria
Exclusion criteria: Allergy to botulinum toxin or formulation components History of treatment with botulinum toxin in the last 6 months Consumption of aminoglycosides, penicillamine, quinine, chloroquine, hydroxychloroquine, calcium channel blockers, in the last week Taking any anticoagulant or aspirin History of any cosmetic surgery on the face (such as filler injection, chemical peeling and laser) or surgery on the facial muscles and scars on the forehead and its surrounding areas History of using products that regenerate the skin or actively change the forehead and surrounding areas (within the last 6 months) Having diseases that can affect neuromuscular activity (such as myasthenia gravis, amyotrophic lateral sclerosis or Eton Elembert) History of facial nerve palsy Significant asymmetry in the face Eyelid or eyebrow ptosis due to facial paralysis or a history of facial paralysis Any active infection or acute skin disease in the injected areas Planned facial cosmetic surgery during the study Severe atrophy or excessive muscle weakness in the target injection areas History of participation in other clinical studies on products or drugs similar to botulinum toxin and fillers History of eyebrow tattooing or any other procedure in the eyebrow area during the last month Pregnancy (according to B-HCG blood test) breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation of abobotulinum toxin type A produced by Ronak Pharmaceutical Company in the treatment of moderate to severe frown lines. Timepoint: on days 3, 14, 28 after injection. Method of measurement: Using the adverse events form. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluating the effectiveness of abobotulinum toxin type A produced by Ronak Pharmaceutical Company in the treatment of moderate to severe frown lines. Timepoint: Days 3, 14 and 28. Method of measurement: GLSS.;The percentage of people with response to treatment in maximum frown and rest. Timepoint: Days 3, 14 and 28. Method of measurement: Based on GLSS. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehran Pouraqajani
Bagheiat-allah University of Medical Sciences
Outcome results
None listed