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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180515039672N3

Enrollment

184

Registered

2020-05-21

Start date

2020-05-21

Completion date

Unknown

Last updated

2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glabellar frown lines. Changes in skin texture

Interventions

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 salin

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Amini Pouya

Arta Zist Pharmed

m.amini@artapharmed.com0098219426001123

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026