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IRCT20180515039672N3 IRCT 2020-05-21 Imen Vaccine Alborz The onset of action and safety of Dyston in glabellar lines improvement The Phase IV study for assessment of the onset of action and Treatment EmergentAdverse Events of Dyston (Botulinum Toxin Type A- ImenVaccine Co.) in Glabellar Lines Improvement 2020-05-21 anticipated 184 Complete https://irct.ir/trial/46483 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 4 Glabellar frown lines. Intervention group: Intramuscular injection of 0.2 to 0.3 milliliter from 500 unit vial of Dyston (botulinum toxin type A-Imen Vaccine Alborz) which is reconstituted in 2.5 milliliters of normal saline, into 3 to 5 injection sites in glabellar muscles at the first visit.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Maryam Amini Pouya
Atam building, Niro street, South Jannat Abad
Tehran Iran (Islamic Republic of) 1473913108 0098219426001123 m.amini@artapharmed.com Arta Zist Pharmed scientific Amir Hooshang Ehsani
Vahdat Eslami street., Vahdat Eslami square
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0223 ehsanih@sina.tums.ac.ir Razi hospital Iran (Islamic Republic of) 18 to 75 year old volunteer Moderate to severe glabellar lines at maximum frown Signed an informed consent form Being agree with 14-day follow up 18 years 75 years Both Hypersensitivity to botulinum toxin or any other ingredients in the formulation Taking the following medicines: aminoglycosides, penicillamine, quinine, chloroquine, hydroxychloroquine, calcium channel blockers, Anticoagulants (warfarin and aspirin) Any aesthetic surgery (e.g. fillers injection, chemical peeling, laser) or any other materials causing remodeling of the skin or active changes in the glabellar area within the last 12 months Previous history of any surgery in the facial muscles or scars in the glabellar area and the surrounding areas (including eyebrows) The medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis) History of facial nerve palsy Marked facial asymmetry History of the eyelid or eyebrow ptosis due to the facial muscle palsy Any active infection or acute skin disease in the injection sites Pregnant or lactating females R23.4 Changes in skin texture Treatment - Drugs Intervention group: Intramuscular injection of 0.2 to 0.3 milliliter from 500 unit vial of Dyston (botulinum toxin type A-Imen Vaccine Alborz) which is reconstituted in 2.5 milliliters of normal saline, into 3 to 5 injection sites in glabellar muscles at the first visit. The onset of action. Timepoint: Daily (immediately after injection till 14 days). Method of measurement: Average (day). Adverse events. Timepoint: Daily (immediately after injection till 14 days). Method of measurement: Percentage. Imen Vaccine Alborz Approved 2020-05-07 Ethics committee of Tehran University of Medical sciences Vice-Chancellor in Research Affairs-Tehran University of Medical Science, 6th floor, at the corner of Qods street, Keshavarz boulevard Tehran Tehran Iran (Islamic Republic of)