Glabellar Facial lines.
Conditions
Interventions
Masport® 500 unit vial manufactured by Masoondarou Co. Each vial contain 500 unit botulinum type a toxin , 0.5 mg human albumin and 2.5 mg lactose . The dose of this product for treatment of glabellar
Treatment - Drugs
Sponsors
Masoondarou Co.
Research Deputy of Ministry of Health
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: male or females age between 18 to 60 years old with moderate to severe glabellar facial lines Exclusion criteria: evidence of any unusual condition in volunteer, i.e.: severe allergic reactions, need for use of corticosteroids, evidence of pregnancy before administration of products and abnormal results of paraclinical tests (leukocytopenia , leukocytosis , thrombocytopenia , anemia , hyperkalemia , hypokalemia , hypernatremia , hyponatremia) .
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence any local and systemic adverse effects. Timepoint: At day 3, 7, 14, 30, 60, 90 and 120 post-injection. Method of measurement: Clinical examination , blood and urine analysis.;Subject Global Assessment of Change (SGA). Timepoint: At days 0 , 3 , 7 , 14 , 30 , 60 and 120 Post-injection. Method of measurement: Subject’s global assessment.;Rating of glabellar line severity at maximum frown. Timepoint: At days 3, 7, 14 and 30 post-injection. Method of measurement: Rating of glabellar line severity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rating of glabellar line severity at rest. Timepoint: At day 30 post-injection. Method of measurement: Rating of glabellar line severity. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Amir Hooshang Ehsani
School of Medicine , Tehran University of Medical Sciences
Outcome results
None listed