Glabellar LinesPhase 3NCT06946160
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
A Phase 3 study testing Abobotulinumtoxin A (Espad Pharmed Darou Co.) and Abobotulinumtoxin A (Ipsen Co.) in people with Glabellar Lines and Glabellar Frown Lines, run by Espad Pharmed at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glabellar Lines, Glabellar Frown Lines
- What is being tested?
- Abobotulinumtoxin A (Espad Pharmed Darou Co.) and Abobotulinumtoxin A (Ipsen Co.)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteIran
- Study dates
- 28 May 2024to 18 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Center for Research and Training in Skin Diseases And Leprosy
Tehran, Tehran Province
About this study
Official title: A Phase I/III, Randomized, Two-armed, Double-blinded, Parallel, Active-controlled, Non-inferiority Clinical Trial to Compare Efficacy and Safety of AbobotulinumtoxinA (Espad Pharmed) Versus AbobotulinumtoxinA (Dysport®, Ipsen Co.) for Correction of Moderate to Severe Glabellar Lines
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.
Read more
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.
Read the 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 is assessed through initial evaluations and review of inclusion and exclusion criteria. At Visit 1, subjects are randomized (1:1) and receive the investigational treatment. Full-face photographs are obtained at Visit 1 (Before receiving the investigational treatment), and at Follow-up Visits 2, 3, 4, and 5, in both resting state and maximum frown. Efficacy is evaluated at Visits 3, 4, and 5. All adverse events are Recorded at all visits.
- Conditions
- Glabellar Lines, Glabellar Frown Lines
- Being tested
- Abobotulinumtoxin A (Espad Pharmed Darou Co.), Abobotulinumtoxin A (Ipsen Co.)
- Keywords
- glabellar lines, AbobotulinumtoxinA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abobotulinumtoxin A (Espad Pharmed Darou Co.)Drug
Vial of Abobotulinumtoxin A (produced by Espad Pharmed Darou Co.), administered via deep intramuscular injection
Abobotulinumtoxin A (Ipsen Co.)Drug
Vial of AbobotulinumtoxinA (Dysport®, produced by Ipsen Co.), administered via deep intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Abobotulinumtoxin A (Ipsen Co.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30
Secondary outcomes (8)
Responders at rest by investigator's assessment
Percentage of responders measured by the investigator's live assessment based on Glabellar Line Severity Scale (GLSS) at rest at days 30, 90 and 120 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.
Measured: Days 30, 90 and 120
Responders at maximum frown by subject's self-assessment
Percentage of responders measured by the subject's self-assessment (SSA) at maximum frown at days 30, 90 and 120 after treatment The 4-grade subject's self-assessment scale defined as follows: 0 = no glabellar lines, 1 = mild lines, 2 = moderate lines, 3 = severe lines. Higher scores indicate more severe glabellar lines. Responders are defined as those reporting a reduction of at least 2 points from baseline.
Measured: days 30, 90 and 120
Responders at rest by subject's self-assessment
Percentage of responders measured by the subject's self-assessment (SSA) at rest at days 30, 90 and 120 after treatment The 4-grade subject's self-assessment scale defined as follows: 0 = no glabellar lines, 1 = mild lines, 2 = moderate lines, 3 = severe lines. Higher scores indicate more severe glabellar lines. Responders are defined as those reporting a reduction of at least 2 points from baseline.
Measured: days 30, 90 and 120
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 days 90 and 120 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.
Measured: days 90 and 120
Total injected dose (visit 1 and touch-up visit)
Measured: Day 14
Onset of action measured by the subject's self-assessment (SSA) at rest
The participants were asked to record the date on which they first noticed the onset of the product's efficacy and to inform the investigator of this date during the visit on day 14.
Measured: Day 14
Onset of action measured by the subject's self-assessment (SSA) at maximum frown
The participants were asked to record the date on which they first noticed the onset of the product's efficacy and to inform the investigator of this date during the visit on day 14.
Measured: Day 14
Safety assessment by evaluation of adverse events (AEs)
Adverse events (AEs) were assessed at all visits. All reported events were classified as mild, moderate, or severe. Moreover, seriousness of Adverse events was assessed according to International Council for Harmonization (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria.
Measured: Visit 0 (screening), visit 1 (Day 0), visit 2 (Day 14), visit 3 (Day 30), visit 4 (Day 90), visit 5 (Day 120)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start28 May 2024
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Espad Pharmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alireza Firooz, Medical Doctor, Principal investigator, Center for Research and Training in Skin Diseases and Leprosy, Tehran, Tehran 1416613675
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946160
- Sponsor's protocol ID
- BOT.ESP.AF.III.02
- Other IDs
- IRCT20150101020514N23
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data produced in the present study are available upon reasonable request from the investigators.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/III, Randomized, Two-armed, Double-blinded, Parallel, Active-controlled, Non-inferiority Clinical Trial to Compare Efficacy and Safety of AbobotulinumtoxinA (Espad Pharmed) Versus AbobotulinumtoxinA (Dysport®, Ipsen Co.) for Correction of Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT06946160
- Acronym / sponsor ID
- BOT.ESP.AF.III.02
- Conditions
- Glabellar Lines, Glabellar Frown Lines
- Keywords
- glabellar lines, AbobotulinumtoxinA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Espad PharmedIndustry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 is assessed through initial evaluations and review of inclusion and exclusion criteria. At Visit 1, subjects are randomized (1:1) and receive the investigational treatment. Full-face photographs are obtained at Visit 1 (Before receiving the investigational treatment), and at Follow-up Visits 2, 3, 4, and 5, in both resting state and maximum frown. Efficacy is evaluated at Visits 3, 4, and 5. All adverse events are Recorded at all visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abobotulinumtoxin A (produced by Espad Pharmed Darou Co.) | Experimental | Drug: Abobotulinumtoxin A (Espad Pharmed Darou Co.)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. |
| Abobotulinumtoxin A (Dysport®, produced by Ipsen Co.) | Active comparator | Drug: Abobotulinumtoxin A (Ipsen Co.)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abobotulinumtoxin A (Espad Pharmed Darou Co.)Vial of Abobotulinumtoxin A (produced by Espad Pharmed Darou Co.), administered via deep intramuscular injection | Drug | Abobotulinumtoxin A (produced by Espad Pharmed Darou Co.) |
| Abobotulinumtoxin A (Ipsen Co.)Vial of AbobotulinumtoxinA (Dysport®, produced by Ipsen Co.), administered via deep intramuscular injection | Drug | Abobotulinumtoxin A (Dysport®, produced by Ipsen Co.) |
Primary outcome
Responders at maximum frown by investigator's assessment
Time frame: Day 30
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.
8 secondary outcomes
Responders at rest by investigator's assessment
Time frame: Days 30, 90 and 120
Responders at maximum frown by subject's self-assessment
Time frame: days 30, 90 and 120
Responders at rest by subject's self-assessment
Time frame: days 30, 90 and 120
Responders at maximum frown by investigator's assessment
Time frame: days 90 and 120
Total injected dose (visit 1 and touch-up visit)
Time frame: Day 14
Onset of action measured by the subject's self-assessment (SSA) at rest
Time frame: Day 14
Onset of action measured by the subject's self-assessment (SSA) at maximum frown
Time frame: Day 14
Safety assessment by evaluation of adverse events (AEs)
Time frame: Visit 0 (screening), visit 1 (Day 0), visit 2 (Day 14), visit 3 (Day 30), visit 4 (Day 90), visit 5 (Day 120)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No. Data produced in the present study are available upon reasonable request from the investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alireza Firooz, Medical Doctor principal investigator
Center for Research and Training in Skin Diseases and Leprosy, Tehran, Tehran 1416613675
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abobotulinumtoxin A (Espad Pharmed Darou Co.) and Abobotulinumtoxin A (Ipsen Co.) in people with Glabellar Lines and Glabellar Frown Lines, run by Espad Pharmed at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responders at maximum frown by investigator's assessment (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.