Upper face wrinkles. Other specified disorders of the skin and subcutaneous tissue
Conditions
Interventions
Intervention group: Injection of Botulinum Toxin Type A (Lucentra®) manufactured by Espad Pharmed Co, supplied in 300- and 500-unit vials.The intervention consists of a single-session injection into t
Sponsors
Espad Pharmed
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Male or female =18 to =65 years of age Willingness for signing and having signed the informed consent form Indication of treatment with botulinum toxin type A in the upper face
Exclusion criteria
Exclusion criteria: Previous treatment with botulinum toxin type A, fillers, skin abrasions, or photo rejuvenation in the upper face 4 months prior to study Any condition or circumstance that might pose a risk to the subject or interfere with the ability to acquire satisfactory clinical data 3. Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of AbobotulinumtoxinA safety. Timepoint: during all scheduled visits. Method of measurement: Assessment of the adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject satisfaction. Timepoint: Day 14, Day 120. Method of measurement: Likert satisfaction scale.;The need for touch-up injections. Timepoint: Day 14. Method of measurement: Physcian assessment.;Total injected dose. Timepoint: Day 14. Method of measurement: Calculating total injected dose.;The onset of action. Timepoint: Day 14. Method of measurement: Subject self assessment (SSA). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hamid reza Kafi
Orchid Pharmed Co
Outcome results
None listed