Frowning line.
Conditions
Interventions
Intervention 1: Intervention group: In this group, the vial containing 500 units of abobotulinum toxin type A manufactured by Ronak Pharmaceutical Company is mixed with 2.5 ml of injectable sodium chl
Sponsors
Ronak Pharmaceutical Co.
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Having informed consent Suffering from moderate to severe frown lines in the state of maximum frown area according to the GLSS criterion 18 to 60 years old
Exclusion criteria
Exclusion criteria: Allergy to botulinum toxin or any of the components of the formulation History of previous treatment with botulinum toxin in the last 6 months Use of aminoglycosides, penicillamine, quinine, chloroquine, hydroxychloroquine, calcium channel blockers, anticoagulants history of any cosmetic surgery (such as filler injection, chemical peeling and laser) in the last year History of using products that regenerate the skin or actively change the forehead area or around it in the last 6 months History of any surgery on facial muscles and forehead scars and surrounding areas (including eyebrows) Any upper facial surgery or cosmetic procedure that may be performed during the study period Diseases that can affect neuromuscular activity (such as myasthenia gravis, amyotrophic lateral sclerosis or Eaton-Lambert) 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 Pregnancy (according to urinary B-HCG test) breastfeeding History of any sensitivity to injectable fillers in the facial area Planned facial cosmetic surgery during the study Severe atrophy or excessive muscle weakness in the target injection areas History of participating in other clinical studies related to botulinum neurotoxin products and fillers within the last 6 months History of eyebrow tattoo or any other procedure in the eyebrow area during the last month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glabellar lines severity (decrease of two or more in the GLSS). Timepoint: It is measured on days 14, 90 and 120 after the intervention. Method of measurement: Glabellar lines severity scale based on GLSS. | — |
Secondary
| Measure | Time frame |
|---|---|
| The degree of effectiveness (reduction of two or more in the GLSS scale) based on the doctor's opinion of the severity of frown lines at rest in the 30th day after injection. Timepoint: in the 30th day after injection. Method of measurement: according to the GLSS.;The degree of effectiveness (reduction of two or more in the GLSS scale) based on the doctor's opinion of the severity of frown lines at rest and the maximum frown according to the GLSS on days 14, 90 and 120 after injection. Timepoint: days14, 90 and 120 after injection. Method of measurement: according to the GLSS.;The degree of effectiveness (reduction of two or more on the GLSS scale) based on the volunteer's opinion of the severity of frown lines in resting states and the maximum frown according to self-assessment (SSA)on days 90, 14, 30 and 120 after injection. Timepoint: days 90, 14, 30 and 120 after injection. Method of measurement: according to self-assessment.;Determining the effective start date based on the evaluation of the candidate. Timepoint: 14th days after injection. Method of measurement: according to self-assessment.;Cumulative dose received in each study group. Timepoint: on days 30, 14, 90 and 120 after injection. Method of measurement: Total doses injected. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehran Pouraghajani
Bagheiat-allah University of Medical Sciences
Outcome results
None listed