Post-Authorization Safety Study (PASS) of Dyston® (Abobotulinum Toxin) to assess its safety

Post-Authorization Safety Study (PASS) of Dyston® (Abobotulinum Toxin) to assess its safety in different dermatological indications

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150101020514N28

Enrollment

1000

Registered

2024-02-17

Start date

2024-02-20

Completion date

Unknown

Last updated

2024-03-06

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 65 Years

Inclusion criteria

Inclusion criteria: Men and women with 18 to 65 years old Mild to moderate Glabellar Lines Signing informed consent form

Exclusion criteria

Exclusion criteria: History of aesthetic procedures on the glabellar area within the last 12 months The medical condition that may affect neuromuscular function History of facial nerve palsy History of the eyelid or eyebrow ptosis 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).	—

Secondary

Measure	Time frame
Adverse events. Timepoint: Daily (immediately after injection till 14 days). Method of measurement: Percentage.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAniseh Samadi

Tehran University of Medical Sciences

dermalab@tums.ac.ir+98 21 8897 2220

Outcome results

None listed

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