Status:
COMPLETED
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
Lead Sponsor:
Espad Pharmed
Conditions:
Glabellar Lines
Glabellar Frown Lines
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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: Abobotulinum...
Detailed Description
The study schedule includes Visit 0 (Screening), Visit 1 (Intervention, Day 0), and Follow-up Visits 2 (Day 14), 3 (Day 30), 4 (Day 90), and 5 (Day 120). At Visit 0, informed consent is obtained, and ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Pregnancy (confirmed by urine test) or lactation.
- Participation in other clinical studies within 30 days prior to randomization or intention to participate in other clinical trials.
- Any other condition or circumstance that may pose a risk to the participant or interfere with the satisfactory completion of the clinical outcome.
- History of participation in other clinical trials involving botulinum neurotoxin products or fillers within the past 6 months.
Key Trial Info
Start Date :
May 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2025
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT06946160
Start Date
May 28 2024
End Date
February 18 2025
Last Update
May 7 2025
Active Locations (1)
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1
Center for Research and Training in Skin Diseases And Leprosy
Tehran, Tehran Province, Iran