A Non-inferiority Clinical Trial to Compare Efficacy and Safety of Abobotulinumtoxin A (Espad Pha… (NCT06946160) | Clinical Trial Compass
CompletedPhase 3
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
Iran146 participantsStarted 2024-05-28
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Responders at maximum frown by investigator's assessment
. 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.