evaluation the effect of botulinum toxin type A for treating frown lines

Comparative evaluation of the safety and efficacy of botulinum toxin type A (product of Imen Vaccine Alborz CO) in comparison with Dysport (standard treatment) for treating glabellar rhytids in people with moderate to severe glabellar rhytids.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150101020514N8

Enrollment

140

Registered

2019-01-30

Start date

2019-02-20

Completion date

Unknown

Last updated

2019-05-21

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

Conditions

skin rejuvenation.

Interventions

Intervention 1: Intervention group: botulinum toxin type A (product of Imen Vaccine Alborz CO) 500iu vial, intra muscular injection, 40-60iu in 2.5 cc normal saline in 3 to 5 point in frontal area in

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Men and women with 18 to 75 years old mild to moderate Glabellar Lines signing informed consent form

Exclusion criteria

Exclusion criteria: Hypersensitivity to botulinum toxin or other components of formulation History of treatment with botulinum toxin in face area within the past 6 months History of using aminoglycosides, penicillin, kinin, chloroquine,Calcium Channel Blockers, warfarin and aspirin History of injectable filler, chemical peels and laser treatment of any type within the past year Significant scarring ,skin disorder or wound infection in the facial area Neuro-muscular disorders like miastenia gravis, iron lambert , ALS Significant face asymmetry Any active, chronic and recurrent infection Pregnancy/ breast feeding

Design outcomes

Primary

Measure	Time frame
Glabellar line severity scale. Timepoint: before intervention and 3, 7, 14, 30, 60, 90 and 120 days later. Method of measurement: physical examination.	—

Secondary

Measure	Time frame
Percentage of subjects with improvement in Glabellar Lines at maximum frown. Timepoint: before intervention and 60, 90 and 120 days later. Method of measurement: GLSS.;Percentage of subjects with improvement in Glabellar Lines at resting. Timepoint: before intervention and 60, 90 and 120 days later. Method of measurement: GLSS.;Percentage of subjects with improvement in Glabellar Lines at maximum frown using SSA scoring. Timepoint: before intervention and 30 and 120 days later. Method of measurement: Subject Self Assessment (SSA).;Percentage of subjects with improvement in Glabellar Lines at rest using SSA scoring. Timepoint: before intervention and 30 and 120 days later. Method of measurement: Subject Self Assessment (SSA).;The onset and duration of the effect of two groups. Timepoint: Days 3, 7, 14, 30, 60, 90, 120 after treatment. Method of measurement: Clinical assessment.;Adverse effects. Timepoint: Days 3, 7, 14, 30, 60, 90, 120 after treatment. Method of measurement: Clinical assessment.	—

Measure

Time frame

Percentage of subjects with improvement in Glabellar Lines at maximum frown. Timepoint: before intervention and 60, 90 and 120 days later. Method of measurement: GLSS.;Percentage of subjects with improvement in Glabellar Lines at resting. Timepoint: before intervention and 60, 90 and 120 days later. Method of measurement: GLSS.;Percentage of subjects with improvement in Glabellar Lines at maximum frown using SSA scoring. Timepoint: before intervention and 30 and 120 days later. Method of measurement: Subject Self Assessment (SSA).;Percentage of subjects with improvement in Glabellar Lines at rest using SSA scoring. Timepoint: before intervention and 30 and 120 days later. Method of measurement: Subject Self Assessment (SSA).;The onset and duration of the effect of two groups. Timepoint: Days 3, 7, 14, 30, 60, 90, 120 after treatment. Method of measurement: Clinical assessment.;Adverse effects. Timepoint: Days 3, 7, 14, 30, 60, 90, 120 after treatment. Method of measurement: Clinical assessment.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAniseh Samadi

Tehran University of Medical Sciences

aniseh_samadi@yahoo.com+98 982188978190

Outcome results

None listed

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