A Non-inferiority Clinical Trial to Compare Efficacy and Safety of Abobotulinumtoxin A (Espad Pharmed) Versus AbobotulinumtoxinA (Dysport®, Ipsen Co.) for Correction of Moderate to Severe Glabellar Lines

NCT06946160 | Completed Phase 3 DMC

• 2 other identifiers: BOT.ESP.AF.III.02IRCT20150101020514N23
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy and safety of AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) for correction of moderate to severe glabellar lines. Hypothesis: AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) has acceptable efficacy and safety profile for correction of moderate to severe glabellar lines. Primary Outcome: To verify the non-inferiority of the efficacy of AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) compared with AbobotulinumtoxinA (Dysport®, produced by Ipsen Co.) by percentage of responders at maximum frown at day 30 after treatment. Researchers will compare the efficacy and safety profile of AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) with AbobotulinumtoxinA (Dysport®, produced by Ipsen Co.). The study is designed as phase III, randomized, two armed, double-blind, parallel, active controlled, non-inferiority clinical trial. Participants received a total dose of 40-60 units into 3 to 5 sites. After two weeks, a touch-up intervention could be done based on physician's assessment.

Conditions

Glabellar Lines; Glabellar Frown Lines

Keywords

glabellar lines; AbobotulinumtoxinA

Outcome Measures

Primary Outcomes (1)

• Responders at maximum frown by investigator's assessment

  Percentage of responders measured by the investigator's live assessment based on Glabellar Line Severity Scale (GLSS) at maximum frown at day 30 after treatment The Glabellar Line Severity Scale (GLSS) is a 4-grade scale defined as follows: 0 = no glabellar lines, 1 = mild lines, 2 = moderate lines, 3 = severe lines. Higher scores indicate more severe glabellar lines. Participants were considered responders if they showed a reduction of at least 2 points from baseline on the scale.

  Day 30

Secondary Outcomes (8)

• Responders at rest by investigator's assessment

  Days 30, 90 and 120

• Responders at maximum frown by subject's self-assessment

  days 30, 90 and 120

• Responders at rest by subject's self-assessment

  days 30, 90 and 120

• Responders at maximum frown by investigator's assessment

  days 90 and 120

• Total injected dose (visit 1 and touch-up visit)

  Day 14

Study Arms (2)

Abobotulinumtoxin A (produced by Espad Pharmed Darou Co.)

EXPERIMENTAL

Vial of AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.), administered via deep intramuscular injection into 3 to 5 sites in the glabellar area using a 1 ml syringe, with a total dose of 40 to 60 International Units (IU), administered in a single treatment session.

Drug: Abobotulinumtoxin A (Espad Pharmed Darou Co.)

Abobotulinumtoxin A (Dysport®, produced by Ipsen Co.)

ACTIVE COMPARATOR

Vial of AbobotulinumtoxinA (Dysport®, produced by Ipsen Co.), administered via deep intramuscular injection into 3 to 5 sites in the glabellar area using a 1 ml syringe, with a total dose of 40 to 60 International Units (IU), administered in a single treatment session.

Drug: Abobotulinumtoxin A (Ipsen Co.)

Interventions

Abobotulinumtoxin A (Espad Pharmed Darou Co.) DRUG

Vial of Abobotulinumtoxin A (produced by Espad Pharmed Darou Co.), administered via deep intramuscular injection

Abobotulinumtoxin A (produced by Espad Pharmed Darou Co.)

Abobotulinumtoxin A (Ipsen Co.) DRUG

Vial of AbobotulinumtoxinA (Dysport®, produced by Ipsen Co.), administered via deep intramuscular injection

Abobotulinumtoxin A (Dysport®, produced by Ipsen Co.)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 to ≤65 years of age
• Willingness for signing and having signed the informed consent form
• Moderate to severe glabellar wrinkle at maximum frown based on glabellar lines severity scale (GLSS)
• be able to participate in the visit schedules and the study procedures.

You may not qualify if:

• Hypersensitivity to botulinum toxin or any other component of the formulation, as well as to injectable fillers in the facial region.
• Previous treatment with botulinum toxin in facial areas within the past 6 months.
• Previous treatment with dermal fillers, dermabrasion, or photo rejuvenation in the glabellar region within the past 12 months.
• History of dermal filler injection in the forehead region within the past year.
• History of eyebrow tattooing or any other procedure involving the eyebrow area within the past month.
• Use of aminoglycosides, penicillamine, quinine, chloroquine, hydroxychloroquine, or calcium channel blockers within the past week.
• Use of anticoagulants or aspirin within the past 10 days (participants are not required to discontinue their anticoagulant therapy to be enrolled in the study).
• History of any cosmetic surgery (e.g., filler injections, chemical peels, or laser treatments) or use of products that induce skin remodeling or significantly affect the forehead area or its surroundings, including any aesthetic procedure involving the glabellar lines within the past 6 months.
• History of any surgical procedure involving facial muscles or scarring in the forehead or surrounding areas (including the eyebrows).
• Any planned aesthetic procedure involving the upper face during the course of the study.
• Presence of disorders that may affect neuromuscular function (e.g., myasthenia gravis, amyotrophic lateral sclerosis \[ALS\], or Eaton-Lambert syndrome).
• History of facial nerve paralysis.
• Presence of clearly visible and defined facial asymmetry.
• Ptosis of the eyelids or eyebrows due to facial muscle paralysis or a history thereof.
• Presence of any active infection or acute dermatological condition in the injection areas.

Sponsors & Collaborators

• Espad Pharmed: lead

Study Sites (1)

Center for Research and Training in Skin Diseases And Leprosy

Tehran, Tehran Province, Iran

Location

MeSH Terms

Interventions

abobotulinumtoxinA

Study Officials

• Alireza Firooz, Medical Doctor

  Center for Research and Training in Skin Diseases and Leprosy, Tehran, Tehran 1416613675

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: April 27, 2025
• Study Start: May 28, 2024
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)