Efficacy and safety of Abobotulinum toxin A Zibonta versus Dysprt® for correction of glabellar line

A phase III, randomized, two armed, double-blinded, parallel, active-controlled, non-inferiority clinical trial to compare efficacy and safety of Abonotulinumtoxin A(Zibonta) (produced by Zist Daru Danesh Company) versus Dysprot®(Ispen Co.) for correction of moderate to severe glabellar line

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150101020514N32

Enrollment

146

Registered

2024-09-05

Start date

2024-12-21

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Glabellar Lines. Changes in skin texture

Interventions

Intervention 1: Intervention group: botulinum toxin type A Zibonta(500iu vial produced by Zist Daru Danesh Company), intra muscular injection, 40-60iu in 3 point in frontal area in one visit. Interve

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: Allergies to botulinum toxin or any other compound in the formulation Previous treatment with botulinum toxin within the last 6 months History of filler injection in glabellar area during the last year History of any alergic reaction to injectable fillers in the facial area History of eyebrow tattoo or any other procedure in the eyebrow area during the last month Planned Facial Cosmetic Surgery (such as filler injection, chemical peeling and laser) Using products that cause skin remodeling or active changes on the forehead area and History of any cosmetic surgery in glabellar area in the last 6 months

Design outcomes

Primary

Measure	Time frame
Percentage of subjects with improvement in Glabellar Lines at maximum frown. Timepoint: 30 days after intervention. Method of measurement: GLSS (Glabellar Lines Severity Score).	—

Secondary

Measure	Time frame
Percentage of subjects with improvement in Glabellar Lines at maximum frown using SSA scoring. Timepoint: Before intervention, 14, 30, 90 and 120 days later. Method of measurement: Subject Self Assessment (SSA).;Percentage of subjects with improvement in Glabellar Lines at resting. Timepoint: Before intervention, 14, 90 and 120 days later. Method of measurement: GLSS (Glabellar Lines Severity Score).;Percentage of subjects with improvement in Glabellar Lines at rest using SSA scoring. Timepoint: Before intervention, 14, 30, 90 and 120 days later. Method of measurement: Subject Self-Assessment (SSA).	—

Measure

Time frame

Percentage of subjects with improvement in Glabellar Lines at maximum frown using SSA scoring. Timepoint: Before intervention, 14, 30, 90 and 120 days later. Method of measurement: Subject Self Assessment (SSA).;Percentage of subjects with improvement in Glabellar Lines at resting. Timepoint: Before intervention, 14, 90 and 120 days later. Method of measurement: GLSS (Glabellar Lines Severity Score).;Percentage of subjects with improvement in Glabellar Lines at rest using SSA scoring. Timepoint: Before intervention, 14, 30, 90 and 120 days later. Method of measurement: Subject Self-Assessment (SSA).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAniseh Samadi

Tehran University of Medical Sciences

aniseh_samadi@yahoo.com+98 21 8896 0880

Outcome results

None listed

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