Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IRCT20150101020514N23 | Registry Identifier | Iranian Registry of Clinical Trials |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abobotulinumtoxin A (Espad Pharmed Darou Co.) | Drug | Vial of Abobotulinumtoxin A (produced by Espad Pharmed Darou Co.), administered via deep intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alireza Firooz, Medical Doctor | Center for Research and Training in Skin Diseases and Leprosy, Tehran, Tehran 1416613675 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Research and Training in Skin Diseases And Leprosy | Tehran | Tehran Province | Iran |
Data produced in the present study are available upon reasonable request from the investigators.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Abobotulinumtoxin A (Ipsen Co.) | Drug | Vial of AbobotulinumtoxinA (Dysport®, produced by Ipsen Co.), administered via deep intramuscular injection |
|
| 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. | 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. | 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. | days 90 and 120 |
| Total injected dose (visit 1 and touch-up visit) | 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. | 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. | 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. | Visit 0 (screening), visit 1 (Day 0), visit 2 (Day 14), visit 3 (Day 30), visit 4 (Day 90), visit 5 (Day 120) |
| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
Not provided
Not provided
Not provided