Comparative study , safety and efficacy ,clinical trial phase III - of Masport in patients with glabellar lines, in compare to a commercial product

Comparison of safety and efficacy of MASPORT® to commercial product in treatment of patients with glabellar lines

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013100214871N1

Enrollment

260

Registered

2013-12-23

Start date

2014-06-08

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Glabellar Line. Disorder of skin and subcutaneous tissue,unspecified

Interventions

Intervention 1: Injection of 50 U botulinum toxin type A -MASPORT® in five injection site between glabellar lines in test group. Intervention 2: Injection of 50 U botulinum toxin type A -DYSPORT®

Treatment - Drugs

Injection of 50 U botulinum toxin type A -MASPORT® in five injection site between glabellar lines in test group

Injection of 50 U botulinum toxin type A -DYSPORT® in five injection site between glabellar lines in control group

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: male or females; age 18 to 60 years old with moderate to severe glabellar lines. Exclusion criteria: No sign of informed consent form; serious side effect; cardiovascular disorder; pulmonary infection / disorder; concomitant administration of neuromuscular drugs; face surgery or peeling.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Glabellar line improvement assessment by investigator. Timepoint: Days 0 and 30 post-injection. Method of measurement: Investigator Rating of glabellar line severity at maximum frown and photography.;Subject Global Assessment of Change (SGA). Timepoint: Days 0 and 30 post-injection. Method of measurement: Subject’s global assessment.;Any local and systemic side effects. Timepoint: At days 0, 14 , 30,60,90 and 120 post-injection. Method of measurement: Clinical evaluation.	—

Measure

Time frame

Glabellar line improvement assessment by investigator. Timepoint: Days 0 and 30 post-injection. Method of measurement: Investigator Rating of glabellar line severity at maximum frown and photography.;Subject Global Assessment of Change (SGA). Timepoint: Days 0 and 30 post-injection. Method of measurement: Subject’s global assessment.;Any local and systemic side effects. Timepoint: At days 0, 14 , 30,60,90 and 120 post-injection. Method of measurement: Clinical evaluation.

—

Secondary

Measure	Time frame
Glabellar line improvement assessment by investigator in maximum frown and at rest. Timepoint: 60, 90 and 120 days after injection . Method of measurement: Investigator Rating of glabellar line severity at rest and maximum frown.;Subject Global Assessment of Change (SGA). Timepoint: Days 60;90 and 120 post-injection. Method of measurement: Subject’s global assessment.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Amir Hooshang Ehsani

School of Medicine, Tehran University of Medical Sciences

ehsanih@sina.tums.ac.ir+98 21 5563 0669

Outcome results

None listed

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