Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-29 @ 4:47 AM
Study NCT ID:
NCT06946160
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2025-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Espad Pharmed
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IRCT20150101020514N23 | REGISTRY | Iranian Registry of Clinical Trials | View |